Linvatec Corp.
Medical device manufacturer in Largo, FL.
93510(k) clearances
0PMA approvals
49recalls
Device types
- HRX Arthroscope 19
- HWC Screw, Fixation, Bone 17
- MAI Fastener, Fixation, Biodegradable, Soft… 11
- MBI Fastener, Fixation, Nondegradable, Soft… 10
- GEI Electrosurgical, Cutting & Coagulation &… 6
- ERL Drill, Surgical, Ent (Electric Or… 5
- GCJ Laparoscope, General & Plastic Surgery 4
- JOS Electrode, Electrosurgical 3
- DZI Drill, Bone, Powered 2
- HBC Motor, Drill, Electric 2
- GEY Motor, Surgical Instrument, Ac-Powered 2
- LXH Orthopedic Manual Surgical Instrument 1
- HET Laparoscope, Gynecologic (And Accessories) 1
- HIG Insufflator, Hysteroscopic 1
- FHO Pneumoperitoneum Needle 1
- HIH Hysteroscope (And Accessories) 1
- HTN Washer, Bolt Nut 1
- HWE Instrument, Surgical, Orthopedic… 1
- JDR Staple, Fixation, Bone 1
- HTY Pin, Fixation, Smooth 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K092998 | Conmed Linvatec Intercept ImplantMBI · Traditional | 12/23/2009SE |
| K091549 | Conmed Linvatec Soft Tissue to Bone SystemMBI · Special | 06/23/2009SE |
| K090835 | Conmed Linvatec Bio Mini-Revo Suture Anchor, Model C6170CRMAI · Traditional | 06/22/2009SE |
| K090186 | Conmed Linvatec Paladin, Preloaded with Two #2 Hi-Fi SuturesMAI · Special | 04/10/2009SE |
| K083281 | El Lightwave Suction Ablator, Model EL-2000-S, Lightwave Suction Ablator, Model…GEI · Traditional | 02/25/2009SE |
| K060198 | Micropower Hand Piece : Medium Speed Drill, Saggital Saw, Reciprocating Saw, and…HRX · Special | 05/11/2006SE |
| K060270 | Micropower Hand Piece: Oral Max High Speed DrillDZI · Special | 04/10/2006SE |
| K060260 | Micropower Hand Piece High Speed DrillHBC · Special | 04/10/2006SE |
| K050519 | Advanced Turbo Drive SystemGEY · Special | 05/17/2005SE |
| K050497 | Bioscrew Xtralok, 8X35MM & 8X40MM VioletHWC · Special | 03/25/2005SE |
| K050227 | Threvo Suture Anchor with Disposable DriverMBI · Special | 03/02/2005SE |
| K043106 | Pinn-Acl CrosspinHTY · Traditional | 01/19/2005SE |
| K042778 | Bioanchor with Disposable Driver, Preloaded with One #2 Herculine SutureHWC · Special | 11/04/2004SE |
| K041128 | Suture ArrowMAI · Traditional | 07/29/2004SE |
| K041713 | Super Revo Herculine Suture AnchorMBI · Special | 07/22/2004SE |
| K033573 | Linvatec 10K Irrigation SystemHRX · Traditional | 02/11/2004SE |
| K033804 | Bioanchor with Disposable DriverHWC · Special | 12/31/2003SE |
| K033748 | Trident Resection AblatorGEI · Special | 12/15/2003SE |
| K032607 | Powerpro Pneumatic System, Models PRO6150, PRO6175, PRO6185DZI · Traditional | 11/10/2003SE |
| K031994 | Linvatec 300W Xenon Light SourceGCT · Traditional | 08/21/2003SE |
| K031098 | 3-CCD Digital Camera SystemGCJ · Traditional | 06/04/2003SE |
| K030720 | Ultrablator ElectrodeGEI · Traditional | 06/03/2003SE |
| K022827 | Ultrafix Knotless Minimite Suture AnchorMBI · Traditional | 11/22/2002SE |
| K013131 | Bioscrew XtralokHWC · Traditional | 06/11/2002SE |
| K020377 | Pre-Loaded Biostinger HornetHWC · Traditional | 05/06/2002SE |
| K013369 | Resection AblatorGEI · Traditional | 04/04/2002SE |
| K013553 | Pre-Loaded Ultrafix RCMBI · Traditional | 12/19/2001SE |
| K013117 | Resection AblatorHRX · Traditional | 11/29/2001SE |
| K012320 | Powerpro Battery SystemHAB · Traditional | 10/19/2001SE |
| K003984 | Super Revo Suture AnchorMAI · Traditional | 03/19/2001SE |
| K002088 | Shaver AblatorHRX · Traditional | 03/06/2001SE |
| K002523 | Advantage Drive SystemHBC · Traditional | 10/06/2000SE |
| K993885 | Ultrablator ElectrodeJOS · Traditional | 02/10/2000SE |
| K993339 | Endopearl with ThreaderMAI · Traditional | 12/10/1999SE |
| K991024 | Bone Bullet Suture AnchorHWC · Traditional | 11/16/1999SE |
| K990194 | BiobuttonHWC · Traditional | 09/17/1999SE |
| K991830 | Capsular Shrinkage ElectrodeJOS · Traditional | 08/20/1999SE |
| K991715 | Biostinger-V Bioabsorbable Meniscal Repair DeviceMAI · Traditional | 08/06/1999SE |
| K990770 | Biorc AnchorHWC · Traditional | 07/30/1999SE |
| K990524 | E9000 SystemHRX · Traditional | 07/15/1999SE |
| K984171 | EndopearlMAI · Traditional | 04/29/1999SE |
| K983652 | Ablator ElectrodeHRX · Traditional | 03/23/1999SE |
| K983186 | Bio-Anchor, Pre-Loaded Bioabsorbable Suture AnchorMAI · Traditional | 10/21/1998SE |
| K981636 | Integrated Drive/Pump SystemHRX · Traditional | 08/20/1998SE |
| K981692 | Meniscal Repair DeviceMBI · Traditional | 07/27/1998SE |
| K981637 | Integrated Drive/Pump System for OtolaryngologyERL · Traditional | 07/20/1998SE |
| K981269 | Universal Drive SystemHRX · Traditional | 06/24/1998SE |
| K974538 | Meniscal Repair DeviceHWC · Traditional | 03/03/1998SE |
| K973758 | Bioscrew Absorbable Interference SrewHWC · Traditional | 02/27/1998SE |
| K963932 | Preloaded Soft Tissue AnchorMBI · Traditional | 06/20/1997SE |
| K971059 | Universal Drive SystemHRX · Traditional | 06/18/1997SE |
| K964805 | Bio-AnchorMAI · Traditional | 06/09/1997SE |
| K963369 | Bio-AnchorMAI · Traditional | 05/22/1997SE |
| K964548 | Apex Universal Drive SystemERL · Traditional | 01/17/1997SE |
| K960652 | Bioscrew Absorbable Interference ScrewHWC · Traditional | 11/14/1996SN |
| K961590 | Apex Universal Irrigation System & Two-Connection Tubing SetHRX · Traditional | 10/08/1996SE |
| K960962 | Interference ScrewHWC · Traditional | 08/19/1996SE |
| K960940 | Bioscrew Absorbable Interference ScrewHWC · Traditional | 08/15/1996SE |
| K961192 | Irrigation SystemERL · Traditional | 04/26/1996SE |
| K960852 | Hall Modular Acetabular Reamer SystemHWE · Traditional | 03/20/1996SE |
| K955486 | Bio-AnchorMAI · Traditional | 02/29/1996SN |
| K953954 | Preloaded Soft Tissue AnchorMBI · Traditional | 02/20/1996SN |
| K954682 | Washer, Bolt, Nut, OrthopedicHTN · Traditional | 02/09/1996SN |
| K955273 | Cannuloc Threaded CannulaHRX · Traditional | 12/08/1995SE |
| K954440 | Apex Tubing SetHRX · Traditional | 11/02/1995SE |
| K953702 | WasherMBI · Traditional | 10/25/1995SE |
| K952831 | Bioscrew Absorbable Interference ScrewHWC · Traditional | 09/15/1995SE |
| K944553 | Pressure Sensing Scope Sheath SystemHRX · Traditional | 09/08/1995SE |
| K941862 | Inteq TFCC Repair SystemHRX · Traditional | 08/14/1995SE |
| K934321 | Linvatec Stasys-Pes Fixation DeviceHWC · Traditional | 05/10/1995SE |
| K944992 | ElectrodesJOS · Traditional | 04/27/1995SE |
| K951263 | Intraarc Drive SystemERL · Traditional | 04/17/1995SE |
| K941651 | CTS Relief KitHRX · Traditional | 01/18/1995SE |
| K933873 | Concept Universal Pump SystemHIG · Traditional | 12/29/1994SE |
| K942447 | Hasson Open Laparoscopy CannulaHET · Traditional | 12/15/1994SE |
| K944476 | Apex Universal Drive SystemERL · Traditional | 11/18/1994SE |
| K942080 | Sensatec Endoscopic InstrumentsGEI · Traditional | 11/17/1994SE |
| K942077 | Bi-Tec Endoscopic Bipolar InstrumentsGEI · Traditional | 11/14/1994SE |
| K943985 | Limited Reuse BladesHRX · Traditional | 11/07/1994SE |
| K941691 | Revo Rotator Cuff Repair SystemHRX · Traditional | 09/06/1994SE |
| K941711 | Hyperflex Flexible GuidewiresLXH · Traditional | 08/26/1994SE |
| K942484 | Verres NeedleFHO · Traditional | 06/24/1994SE |
| K942414 | Trocar Sleeve, Sealing Caps, Reducer, Loop GuideGCJ · Traditional | 06/21/1994SE |
| K922420 | Continuous Flow Hystero-ResectoscopeHIH · Traditional | 06/14/1994SE |
| K942415 | R-Bar RetractorGCJ · Traditional | 06/13/1994SE |
| K942416 | Hasson GraspersGCJ · Traditional | 06/08/1994SE |
| K940515 | Poly BladesHRX · Traditional | 05/26/1994SE |
| K933719 | Bioscrew Absorbable Interference ScrewHWC · Traditional | 05/17/1994SN |
| K934379 | Linvatec Powerlink Surgical Shaving SystemHRX · Traditional | 04/15/1994SE |
| K933352 | Concept Cannulated Intereference ScrewHWC · Traditional | 02/23/1994SN |
| K932700 | Cuto(Tm) Tissue Morcellation SystemGEY · Traditional | 10/15/1993SE |
| K924941 | Concept 4MM Cancellous Screw with EyeletJDR · Traditional | 06/04/1993SE |
| K922186 | Hem-O-Lok -- ModificationGDW · Traditional | 08/06/1992SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0406-2009 | ConMed Linvatec Hall Surgical Blades, Sterile THIN X-FINE, Catalog # L135 ConMed…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0405-2009 | ConMed Linvatec Hall Surgical Blades, Sterile STERILE REPL BLD/STRYKER, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0404-2009 | ConMed Linvatec Hall Surgical Blades, Sterile STERILE ACL BLD, Catalog # 00502318200…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0403-2009 | ConMed Linvatec Hall Surgical Blades, Sterile STER RPLCMNT BLADE/STRYKER RECIP, Catalog…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0402-2009 | ConMed Linvatec Hall Surgical Blades, Sterile STER REPT STERNTMY BLD, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0401-2009 | ConMed Linvatec Hall Surgical Blades, Sterile STER OSC BLD, Catalog # 00507118000…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0400-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST STERNUM SAW BLADES, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0399-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST SAGITTAL BLD FINE, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0398-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST SAG/OSC BLADE, Catalog # 00505928200…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0397-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST SAG BLADE, Catalog # 00502314400…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0396-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST SAG BLDE CRS, Catalog # 00502313300…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0395-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST SAG BLD FN 70D, Catalog # 00502312900…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0394-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST REPL STRYKER SAG, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0393-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST REPL BLADE/STRYKER RECIP, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0392-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST REPL BLADE/SARNS STERNUM SAW, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0391-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST REPEAT STERN BLADE, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0390-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST RECIPROCATOR BLADE, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0389-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST OSCIL BLD,ME-92 COATED, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0388-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST OSCIL BLD, Catalog # 00507157200…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0387-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST OSCIL BLADE, ME-92 COAT, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0386-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST OSC BLDE, Catalog # 00507155200…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0385-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST OSC BLDE RADSD, Catalog # 00502316500…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0384-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST OSC BLDE FINE, Catalog # 00502316100…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0383-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST OSC ABRASION BLADE, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0382-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST OSC BLD, Catalog # 00507114500…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0381-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST MICRO RECIP SAW BLADES, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0380-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST MICRO OSCILLSAW BLADE, ANG, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0379-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST EXTENDED STERNUM SAW BLADES, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0378-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST BLD BRZL NEXGEN, Catalog #00507120100…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0377-2009 | ConMed Linvatec Hall Surgical Blades, Sterile ST ACL BLADE, Catalog # 00502318500 and…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0376-2009 | ConMed Linvatec Hall Surgical Blades, Sterile Catalog ADVANCED CUT SAG SAW BLD, Catalog…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0375-2009 | ConMed Linvatec Hall Surgical Blades, Sterile SAGITTAL SAW BLADE THIN, Catalog # K132…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0374-2009 | ConMed Linvatec Hall Surgical Blades, Sterile SAGITTAL SAW BLADE, Catalog # K121, K141…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0373-2009 | ConMed Linvatec Hall Surgical Blades, Sterile SAG BLADE Bent or Angled, Catalog # U335…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0372-2009 | ConMed Linvatec Hall Surgical Blades, Sterile REPEAT STERNOTOMY BLADE, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0371-2009 | ConMed Linvatec Hall Surgical Blades, Sterile RECIPROCATOR BLADE, Catalog # 00505226000…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0370-2009 | ConMed Linvatec Hall Surgical Blades, Sterile RECIP SAW BLADE, Catalog # U773 and P513…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0369-2009 | ConMed Linvatec Hall Surgical Blades, Sterile OSCILLATING KNEE BLADE, Catalog # L192 and…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0368-2009 | ConMed Linvatec Hall Surgical Blades, Sterile OSCBLD, Catalog # 00507158900 and…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0367-2009 | ConMed Linvatec Hall Surgical Blades, Sterile OSC SAW BLAD, Catalog # L121, L122, L145…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0366-2009 | ConMed Linvatec Hall Surgical Blades, Sterile OSC BLADE, Catalog # 00507116100 and…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0365-2009 | ConMed Linvatec Hall Surgical Blades, Sterile MICRO SAG SAW BLADE FINE, Catalog #…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0364-2009 | ConMed Linvatec Hall Surgical Blades, Sterile MAX DRV OSC BLD, Catalog # 00507318100.…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0363-2009 | ConMed Linvatec Hall Surgical Blades, Sterile LG BONE OSC BLADE, Catalog #00507154800…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0362-2009 | ConMed Linvatec Hall Surgical Blades, Sterile INTEX BLADE, Catalog # 00507132000…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0361-2009 | ConMed Linvatec Hall Surgical Blades, Sterile FREE HAND SAW BLADE MICRO CHOICE, Catalog…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0360-2009 | ConMed Linvatec Hall Surgical Blades, Sterile OSC/SAG BLADE, Catalog # U655, U554, and…Sterility compromised. There is a possibility that certain catalog number and lots of ConMed Linvatec Hall… | 02/21/2008Terminated |
| Z-0711-2008 | ConMed Linvatec, Ultrapower Burs, Linvatec Corporation, Largo, FL 33773Compromised sterility: ConMed Linvatec medical devices packaged within a certain Peel Pouch Sterile Package… | 08/09/2007Terminated |
| Z-0179-2007 | ConMed Linvatec Sternum Saw Collet Nut, Catalog Number 5059-09: Used on ConMed Linvatec…The Sternum Saw Collet Nut that is used to insert and hold the saw blade in place may not always allow for… | 12/20/2005Terminated |