Cement, Bone, Vertebroplasty
FDA product code NDN · Class II (moderate risk) · 21 CFR 888.3027 · Orthopedic
108510(k) clearances
0PMA approvals
86recalls
Implantimplanted device
Manufacturers
- Stryker Corporation 7
- Arthrocare Corp. 6
- Tecres S.P.A. 5
- Medtronic, Inc. 5
- Teknimed, S.A. 4
- Disc-O-Tech Medical Technologies, Ltd. 4
- Dfine, Inc. 4
- Pan Medical , Ltd. 3
- Osseon, LLC 3
- Xelite Biomed , Ltd. 3
- Stryker Instruments, Instruments Div. 2
- Kyphon, Inc. 2
- Care Fusion 2
- Aap Biomaterials GmbH & Co. KG 2
- Bm Korea Co., Ltd. 2
- Cardinal Health 2
- Medtronic Sofamor Danek 2
- Imedicom Co., Ltd. 2
- Benvenue Medical, Inc. 2
- Depuy Spine, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251896 | XeliteMed SuperM-Fix Spinal Bone CementNDN · Traditional | Xelite Biomed , Ltd. | 01/28/2026SE |
| K250637 | VCFix Spinal SystemNDN · Traditional | Amber Implants | 05/30/2025SE |
| K243537 | XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemNDN · Traditional | Xelite Biomed , Ltd. | 04/11/2025SE |
| K241775 | XeliteMed VertehighFix High Viscosity Spinal Bone CementNDN · Traditional | Xelite Biomed , Ltd. | 09/18/2024SE |
| K232842 | Balloon Inflation SystemNDN · Traditional | Ningbo Hicren Biotechnology Co., Ltd. | 02/29/2024SE |
| K240084 | V-STRUT® Vertebral ImplantNDN · Special | Hyprevention | 02/09/2024SE |
| K231340 | Renova Spine Balloon CatheterNDN · Traditional | Biopsybell S.R.L. | 10/30/2023SE |
| K221697 | Injection Pin (KIP(02031-02061) (03031-03061))NDN · Traditional | Slk Ortho, LLC | 03/03/2023SE |
| K223294 | SpineJack® Expansion KitNDN · Traditional | Stryker Instruments | 12/20/2022SE |
| K220131 | KYPHON VuE Bone CementNDN · Traditional | Tecres S.P.A. | 04/18/2022SE |
| K211797 | TRACKER Plus Kyphoplasty SystemNDN · Traditional | GS Medical Co., Ltd. | 10/28/2021SE |
| K211238 | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…NDN · Traditional | Stryker Instruments | 06/25/2021SE |
| K202393 | SpineJack Expansion KitNDN · Traditional | Stryker Corporation | 10/20/2020SE |
| K201831 | CONFIDENCE Spinal Cement SystemNDN · Traditional | Depuy Spine, Inc. | 08/31/2020SE |
| K192449 | Joline Kyphoplasty System AllevoNDN · Traditional | Joline GmbH & Co. KG | 05/27/2020SE |
| K191709 | V-STRUT Vertebral ImplantNDN · Traditional | Hyprevention Sas | 03/05/2020SE |
| K192335 | TRACKER Kyphoplasty SystemNDN · Traditional | GS Medical Co., Ltd. | 12/04/2019SE |
| K192403 | VK100 Percutaneous Vertebral Augmentation SystemNDN · Traditional | Bonwrx, Ltd. | 11/08/2019SE |
| K181262 | SpineJack Expansion KitNDN · Traditional | Vexim SA | 08/30/2018SE |
| K172871 | SpineKure Kyphoplasty SystemNDN · Traditional | Hanchang Co., Ltd. | 05/29/2018SE |
| K180700 | KYPHON HV-R Bone CementNDN · Traditional | Medtronic Sofamor Danek USA, Inc. | 05/18/2018SE |
| K172214 | Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersNDN · Special | G-21 S.R.L. | 08/23/2017SE |
| K161114 | High V+NDN · Traditional | Teknimed Sas | 04/12/2017SE |
| K163032 | Kyphon Xpede Bone CementNDN · Traditional | Medtronic, Inc. | 02/27/2017SE |
| K162283 | DCM Kyphoplasty SystemNDN · Traditional | Dragon Crown Medical Co., Ltd. | 02/06/2017SE |
| K162618 | CONCORD Plus Radiopaque Bone CementNDN · Traditional | Globus Medical, Inc. | 01/23/2017SE |
| K162453 | 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)NDN · Special | Pan Medical , Ltd. | 11/01/2016SE |
| K160983 | Kyphon HV-R Bone CementNDN · Traditional | Medtronic, Inc. | 08/24/2016SE |
| K153296 | MEDINAUT Kyphoplasty SystemNDN · Traditional | Imedicom Co., Ltd. | 07/29/2016SE |
| K152557 | Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon CathetersNDN · Traditional | G21, S.R.L. | 02/23/2016SE |
| K151227 | KYPHON XPEDE Bone CementNDN · Traditional | Medtronic | 11/16/2015SE |
| K150582 | Vertaplex® High Viscosity (HV) Radiopaque Bone CementNDN · Traditional | Stryker Corporation | 06/12/2015SE |
| K150460 | KYPHON (R) HV-R(R) Bone CementNDN · Traditional | Medtronic Sofamor Danck USA, Inc. | 04/28/2015SE |
| K150607 | Osseoflex SB Straight Balloon, 10g/4ml, Osseoflex SB Straight Balloon, 10g/2mlNDN · Special | Osseon, LLC | 04/09/2015SE |
| K150322 | InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV Kyphoplasty Catheter…NDN · Special | Pan Medical , Ltd. | 03/06/2015SE |
| K143006 | GUARDIAN-SG Inflatable Bone Expander SystemNDN · Traditional | Bm Korea Co., Ltd. | 01/16/2015SE |
| K141419 | ZvplastyNDN · Traditional | Zavation, LLC | 09/12/2014SE |
| K141930 | Osseoflex SB, 10G/4ML, Osseoflex SB, 10G/2MLNDN · Special | Osseon, LLC | 08/21/2014SE |
| K141141 | Kiva VCF Treatment SystemNDN · Traditional | Benvenue Medical, Inc. | 08/14/2014SE |
| K140937 | Osseoflex SBNDN · Special | Osseon, LLC | 06/19/2014SE |
| K132620 | Inter V Kyphoplasty Catheter (Balloon Length: 0 MM), Interv Kyphoplasty Catheter…NDN · Traditional | Pan Medical , Ltd. | 04/16/2014SE |
| K133669 | Medinaut Kyphoplasty SystemNDN · Traditional | Imedicom | 04/04/2014SE |
| K132817 | Kiva VCF Treatment SystemNDN · Traditional | Benvenue Medical, Inc. | 01/24/2014SE |
| K133372 | Crosstrees Pva PodNDN · Special | Crosstrees Medical, Inc. | 12/06/2013SE |
| K130089 | Crosstrees Pva PodNDN · Traditional | Crosstrees Medical, Inc. | 08/09/2013SE |
| K122503 | Parallax Balloon Inflatable Bone TAMP-10 MM Balloon Parallax Balloon Inflatable Bone…NDN · Traditional | Neuro Therm, Inc. | 06/25/2013SE |
| K130146 | Synthes Synflate Vertevral Balloon SystemNDN · Traditional | Synthes (Usa), LLC | 05/20/2013SE |
| K123942 | Stryker Ivas Balloon CatheterNDN · Traditional | Stryker Corporation | 04/03/2013SE |
| K130402 | Spider System Kolibri Cement NeedleNDN · Special | Sintea Plustek, LLC | 04/01/2013SE |
| K122175 | Mendec Spine HV, Mendec Spine HV SystemNDN · Traditional | Tecres S.P.A. | 03/28/2013SE |
| K100404 | Ascendx VCF Reduction SystemNDN · Traditional | Aoi Medical, Inc. | 12/14/2012SE |
| K122533 | Osseoflex SB Inflatable Bone TampNDN · Traditional | Osseon Therapeutics, Inc. | 10/23/2012SE |
| K121876 | Vertecem II Cement KitNDN · Abbreviated | Aap Biomaterials GmbH | 10/19/2012SE |
| K113742 | KMC Kyphoplasty SystemNDN · Traditional | Shanghai Kinetic Medical Co., Ltd. | 09/17/2012SE |
| K113452 | Acu-Cut Vertebral Augmentation SystemNDN · Traditional | Ascendx Spine, Inc. | 02/17/2012SE |
| K113154 | Ivas Balloon CatheterNDN · Traditional | Stryker Corporation | 01/24/2012SE |
| K113477 | Ivas 20MM (10 Gauge) Balloon CatheterNDN · Traditional | Stryker Instruments, Instruments Div. | 01/06/2012SE |
| K112907 | Confidence High Viscosity Spinal Cement, 16G / 20GNDN · Traditional | Medos International SARL | 12/22/2011SE |
| K110604 | VBB SystemNDN · Traditional | Synthes | 12/13/2011SE |
| K093477 | Shield Kyphoplasty SystemNDN · Traditional | Soteira, Inc. | 12/08/2011SE |
| K111593 | Guardian Inflatable Bone Expander SystemNDN · Traditional | Bm Korea Co., Ltd. | 11/18/2011SE |
| K110998 | Affirm (TM) VCF SystemNDN · Traditional | Algea Therapies | 10/25/2011SE |
| K103807 | Ivas 2-10MM (10 Guage) Ballon CatheterNDN · Traditional | Stryker Corporation | 06/28/2011SE |
| K102397 | Kyphon Xpede Bone CementNDN · Traditional | Medtronic | 02/28/2011SE |
| K110183 | Arthrocare Parallax Contour Vertebral Augmentation DeviceNDN · Special | Arthrocare Corp. | 02/16/2011SE |
| K103816 | Cohesion Bone CementNDN · Special | Teknimed Sas | 02/04/2011SE |
| K103064 | Avamax Vertebral BalloonNDN · Traditional | Care Fusion | 01/10/2011SE |
| K103433 | F20NDN · Special | Teknimed, S.A. | 01/03/2011SE |
| K100479 | Parallax Contour Vertebral Augmentation DeviceNDN · Traditional | Arthrocare Corp. | 09/21/2010SE |
| K093828 | Kyph X Hv-R Bone CementNDN · Special | Medtronic, Inc. | 08/12/2010SE |
| K093419 | Ivas 2-10MM (10 Gauge) Balloon Catheter, Ivas 2-15 MM(10 GAUGE)0705-115-500, Ivas…NDN · Traditional | Stryker Instruments, Instruments Div. | 03/18/2010SE |
| K093463 | Avamax Vertebral Balloon Model VBS1010, VBS1015, VBS1020NDN · Traditional | Care Fusion | 02/26/2010SE |
| K091234 | Skeltex IsvNDN · Traditional | Skeltex Technologies, Inc. | 02/16/2010SE |
| K090986 | Stabili Erx Bone Cement, Model 1135,STABILIT Vertebral Augmentation System (for Use W/…NDN · Traditional | Dfine, Inc. | 12/30/2009SE |
| K090435 | VertecemNDN · Special | Teknimed, S.A. | 12/21/2009SE |
| K091606 | Vertaplex HV (Single Pack and Dual Pack)NDN · Traditional | Stryker Corp. | 10/23/2009SE |
| K090211 | Inflatable Bone TampNDN · Traditional | Cardinal Health, Inc. | 07/01/2009SE |
| K080108 | Cortoss Bone Augmentation MaterialNDN · Traditional | Orthovita, Inc. | 06/05/2009SE |
| K090460 | Bonos InjectNDN · Abbreviated | Aap Biomaterials GmbH | 04/14/2009SE |
| K080873 | Opacity + Bone CementNDN · Special | Teknimed, S.A. | 08/28/2008SE |
| K071375 | Mesh Fenestrated Introducer Needle (Mesh Introducer Needle)NDN · Traditional | Disc-O-Tech Medical Technologies, Ltd. | 12/21/2007SE |
| K072118 | Stryker Vertaplex Radiopaque Bone CementNDN · Traditional | Stryker Corp. | 12/07/2007SE |
| K071927 | Modification to Vertebroplastic Radiopaque Bone CementNDN · Special | Depuy Spine, A Johnson & Johnson Company | 11/21/2007SE |
| K072133 | Avaflex Vertebral Augmentation NeedleNDN · Traditional | Cardinal Health, Inc. | 11/20/2007SE |
| K072496 | Modification to Space Cpsxl Bone CementNDN · Special | Dfine, Inc. | 10/05/2007SE |
| K070351 | Space 360 Delivery SystemNDN · Traditional | Dfine, Inc. | 06/29/2007SE |
| K070527 | Arcuate Vertebral Augmentation SystemNDN · Traditional | Medtronic Sofamor Danek | 05/04/2007SE |
| K063248 | Arcuate Vertebral Augmentation SystemNDN · Traditional | Medtronic Sofamor Danek | 03/13/2007SE |
| K063438 | VspspnNDN · Traditional | Tecres S.P.A. | 01/17/2007SE |
| K063067 | Confidence Fenestrated Introducer NeedleNDN · Special | Disc-O-Tech Medical Technologies, Ltd. | 11/03/2006SE |
| K062452 | Kit Mendec Spine and Delivery SystemNDN · Special | Tecres S.P.A. | 09/21/2006SE |
| K062424 | Confidence Ex High Viscosity Bone CementNDN · Special | Disc-O-Tech Medical Technologies, Ltd. | 09/14/2006SE |
| K061531 | Space Cpsxl Bone CementNDN · Traditional | Dfine, Inc. | 08/30/2006SE |
| K060425 | Parallax Acrylic Resin Cartridge with Tracers-TaNDN · Traditional | Arthrocare Corp. | 07/12/2006SE |
| K053336 | Staxx FX SystemNDN · Traditional | Spine Wave, Inc. | 07/03/2006SE |
| K060300 | Confidence High Viscosity Bone CementNDN · Traditional | Disc-O-Tech Medical Technologies, Ltd. | 06/21/2006SE |
| K043593 | Spine-Fix Biomimetic Bone CementNDN · Traditional | Teknimed, S.A. | 03/17/2006SE |
| K060148 | Ebi Vertebroplasty SystemsNDN · Traditional | Ebi, L.P. | 03/13/2006SE |
| K053180 | Parallax Acrylic Resin Cartridge with TracersNDN · Traditional | Arthrocare Corp. | 01/25/2006SE |
| K042691 | Vertefix Vertebroplasty Procedure SetNDN · Traditional | Cook, Inc. | 11/08/2005SE |
| K043406 | Vertebroplastic Radiopaque Bone CementNDN · Traditional | Depuy Spine, Inc. | 07/15/2005SE |
| K050864 | Parallax Acrylic Resin with Tracers TaNDN · Traditional | Arthrocare Corp. | 06/17/2005SE |
| K042415 | Mendec SpineNDN · Traditional | Tecres S.P.A. | 06/09/2005SE |
| K043518 | Radiopaque Bone CementNDN · Traditional | Cardinalhealth | 05/11/2005SE |
| K042168 | CONCORD Radiopaque Bone CementNDN · Traditional | Globus Medical, Inc. | 01/14/2005SE |
| K042947 | Parallax Acrylic Resin with Tracers, Model KP-PAR-003NDN · Traditional | Arthrocare Corp. | 12/27/2004SE |
| K041584 | Kyphx Hv-R Bone Cement, Model C01ANDN · Traditional | Kyphon, Inc. | 07/07/2004SE |
| K033801 | Kyphx Hv-R, Model C01ANDN · Traditional | Kyphon, Inc. | 04/01/2004SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1099-2023 Class II | HIGH V+ Spinal Cement System REF T040321KIncorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is… | Teknimed SAS | 12/15/2022Open, Classified |
| Z-2101-2021 Class II | Cortoss Bone Augmentation Material 10cc Cartridge, Catalog Number 2101-0010, GTIN…The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the… | Stryker Spine | 05/18/2021Terminated |
| Z-2100-2021 Class II | Cortoss Bone Augmentation Material 5cc Cartridge, Catalog Number 2101-0005, GTIN…The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the… | Stryker Spine | 05/18/2021Terminated |
| Z-1770-2021 Class II | VERTEBREX SINGLE BALLOON KIT, REF VBRX-20-SBK-10. For use in Orthopedic / spinal…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1769-2021 Class II | VERTEBREX SINGLE BALLOON KIT, REF VBRX-15-SBK-10. For use in Orthopedic / spinal…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1768-2021 Class II | OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1767-2021 Class II | ZVPlasty, 11G, 15mm Traditional Bipedicular Kit, REF VCF-1115-2. For use in Orthopedic /…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1766-2021 Class II | ZVplasty System, 20mm, Part# VCF-1020-2. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1765-2021 Class II | ZVplasty 10G, 20mm, Traditional Unipedicular Kit, REF VCF-1020-1. For use in Orthopedic…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1764-2021 Class II | ZVplasty 10G, 15mm Single Balloon Kit, REF VCF-SBK. For use in Orthopedic / spinal…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1763-2021 Class II | ZVplasty 10G, FLEX KYPHOPLASTY, REF VCF-1015-FLEX. For use in Orthopedic / spinal…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1762-2021 Class II | ZVplasty System, 15mm, Part Numbers: a) VCF-1015-2 b) VCF-1015-2A. For use in Orthopedic…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1761-2021 Class II | ZVplasty 10G, 15mm, Additional Level Kit, REF VCF-1015-1A. For use in Orthopedic /…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1760-2021 Class II | ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1759-2021 Class II | ZVplasty System, 15mm, Part# VCF-1015-1. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1758-2021 Class II | ZVplasty, 10G, 10mm Double Balloon Kit, REF VCF-1010-DBK. For use in Orthopedic / spinal…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1757-2021 Class II | ZVplasty System, 10mm, Pat# VCF-1010-2. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1756-2021 Class II | OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For use in Orthopedic…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1755-2021 Class II | InterV 11G Kyphoplasty Kit, REF Numbers: a) INTVMN-10-DSK b) INTVMN-15-DSK c)…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1754-2021 Class II | InterV 10G Bone Access Tools/Kit, REF INTVM-FLNK. For use in Orthopedic / spinal…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1753-2021 Class II | InterV CurvePlus Kit, REF Numbers: a) INTVMC-15-FLDSK b) INTVMC-20-FLDSK. For use in…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1752-2021 Class II | InterV, 10G FLEX Kyphoplasty, REF Number: a) INTVM-15-FLDSK b) INTVM-20-FLDSK. For use…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1751-2021 Class II | InterV, 10G Kyphoplasty Kits, REF numbers: a) INTVM-10-DSK b) INTVM-10-SBK c)…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1750-2021 Class II | CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. For use in Orthopedic / spinal…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1749-2021 Class II | 10 GAUGE DIRECT UNILATERAL STYLET (1 X DIAMOND 1 X BEVEL) STERILE. For use in Orthopedic…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1748-2021 Class II | 10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1747-2021 Class II | 10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1746-2021 Class II | 10 GAUGE DRILL STERILE. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1745-2021 Class II | 10G COAXIAL CANNULA WITH TUOHY CONNECTION STERILE. For use in Orthopedic / spinal…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1744-2021 Class II | 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Orthopedic /…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1743-2021 Class II | 10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1742-2021 Class II | 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1741-2021 Class II | 10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1740-2021 Class II | 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1739-2021 Class II | 11G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1738-2021 Class II | 10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1737-2021 Class II | 11G DIAMOND TROCAR/CANNULA. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1736-2021 Class II | 11G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1735-2021 Class II | 10G SINGLE CEMENT DELIVERY KIT (5 FILLERS). For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1734-2021 Class II | 10G DIRECT SINGLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1733-2021 Class II | 10G BEVELED TROCAR/CANNULA. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1732-2021 Class II | ZVplasty Cement Delivery Cannula, REF VCF-1007. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1731-2021 Class II | 10 Gauge Drill, CODE: INTVM-DRL. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1730-2021 Class II | 10 G Coxaxial Cannula with Tuohy Connection, CODE: INTVM-CC. For use in Orthopedic /…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1729-2021 Class II | ZVplasty Direct Bipedicular Bone Access Kit with Drill, 11 Gauge, REF VCF-DDBAK-11. For…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1728-2021 Class II | ZVplasty Direct Access Diamond Tip Trocar, 11 Gauge, REF VCF-1023-11. For use in…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1727-2021 Class II | 10G DIRECT SINGLE - ACCESS, CODE: INTV-DWCb. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1726-2021 Class II | ZVplasty Directional Cement Cannula (4 pieces per pack), REF VCF-1080-S4. For use in…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1725-2021 Class II | ZVplasty Directional Cement Cannula Long, REF VCF-1080-L. For use in Orthopedic / spinal…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |
| Z-1724-2021 Class II | ZVplasty Direct Access Bevel Tip Trocar, 11 Gauge, REF VCF-1022-11. For use in…Products distributed as sterile may not have been adequately sterilized | Zavation | 03/25/2021Terminated |