Zavation
Medical device manufacturer in Flowood, MS.
15510(k) clearances
0PMA approvals
71recalls
Device types
- KWQ Appliance, Fixation, Spinal Intervertebral… 4
- MAX Intervertebral Fusion Device With Bone… 3
- MNI Orthosis, Spinal Pedicle Fixation 1
- ODP Intervertebral Fusion Device With Bone… 1
- OVE Intervertebral Fusion Device With… 1
- NDN Cement, Bone, Vertebroplasty 1
- OVD Intervertebral Fusion Device With… 1
- MNH Orthosis, Spondylolisthesis Spinal Fixation 1
- PEK Spinous Process Plate 1
- NKG Posterior Cervical Screw System 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K162206 | Zavation IBFMAX · Traditional | 04/04/2017SE |
| K162575 | Z-LINKPC SystemNKG · Traditional | 03/03/2017SE |
| K162824 | Z-Span Plate SystemKWQ · Traditional | 02/17/2017SE |
| K161016 | Z-Clamp ISP SystemPEK · Traditional | 10/19/2016SE |
| K153404 | Zavation Spinal SystemMNH · Traditional | 04/21/2016SE |
| K160362 | Z-Span Plate SystemKWQ · Traditional | 03/22/2016SE |
| K142392 | Zavation Posterior LEIFMAX · Traditional | 04/29/2015SE |
| K142271 | Zavation Z-Link LumbarOVD · Traditional | 12/19/2014SE |
| K141419 | ZvplastyNDN · Traditional | 09/12/2014SE |
| K141005 | Z-Link CervicalOVE · Traditional | 08/07/2014SE |
| K130030 | Zavation Cervical Plate SystemKWQ · Traditional | 04/25/2013SE |
| K120576 | Zavation Ibf SystemMAX · Special | 03/28/2012SE |
| K112664 | Zavation Ibf SystemsODP · Traditional | 12/23/2011SE |
| K112533 | Zavation Cervical Plate SystemKWQ · Traditional | 12/08/2011SE |
| K112484 | Zavation Spinal SystemMNI · Traditional | 11/22/2011SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 03/25/2021Terminated |
| Z-1723-2021 Class II | ZVplasty Biopsy Device, 11 Gauge, REF VCF-1010-11. For use in Orthopedic / spinal…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1722-2021 Class II | ZVplasty Biopsy Device, 10 Gauge, REF VCF-1010. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1721-2021 Class II | ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1720-2021 Class II | 10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1719-2021 Class II | 11G DIRECT WORKING CANNULA DIAMOND TIP MINI, CODE: INTVMN-DWCD. For use in Orthopedic /…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1718-2021 Class II | 10 GAUGE CEMENT DELIVERY CANNULA, CODE: INTVM-CDC. For use in Orthopedic / spinal…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1717-2021 Class II | 11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1716-2021 Class II | 10 GAUGE DIRECT ACCESS DIAMOND TIP, CODE: INTVM-DWCd. For use in Orthopedic / spinal…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1715-2021 Class II | 10G DIRECT SINGLE - ACCESS, CODE INTVM-DSBAK. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1714-2021 Class II | 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKbd. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1713-2021 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 | 03/25/2021Terminated |
| Z-1712-2021 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 | 03/25/2021Terminated |
| Z-1711-2021 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 | 03/25/2021Terminated |
| Z-1710-2021 Class II | ZVplasty Bipedicular Cement Delivery Cannula, 11 Gauge, REF VCF-DCDK-11. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1709-2021 Class II | ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCG-SCDK. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1708-2021 Class II | ZVplasty Direct Unipedicular Bone Access Kit with Drill, 10 Gauge, REF VCF-DSBAK. For…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1707-2021 Class II | ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula, REF VCF-DDSKbd. For…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1706-2021 Class II | ZVplasty Direct Bipedicular Bone Access Kit with Drill, 10 Gauge, VCF-DDBAK. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1705-2021 Class II | ZVplasty, Bipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-DCDK. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1704-2021 Class II | ZVplasty Direct Access Diamond Tip Trocar, 10 Gauge, REF VCF-1023. For use in Orthopedic…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1703-2021 Class II | ZVplasty Direct Access Beveled Tip Trocar, 10 Gauge, REF VCF-1022. For use in Orthopedic…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1702-2021 Class II | ZVplasty Drill, 10 Gauge, REF VCF-1006. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1701-2021 Class II | 10 GAUGE CEMENT DELIVERY CANNULA, INTVM-CDC. For use in Orthopedic / spinal procedures.Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |
| Z-1700-2021 Class II | 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in…Products distributed as sterile may not have been adequately sterilized | 03/25/2021Terminated |