Product code MRW ยท Class U
System, Facet Screw Spinal Device
7510(k)s in 12 months (79 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in MRW
| Company | 510(k)s | Recalls |
|---|---|---|
| Providence Medical Technology, Inc. | 9 | 0 |
| SurGenTec, LLC | 6 | 0 |
| Interventional Spine, Inc. | 2 | 2 |
| Medtronic Sofamor Danek, Inc. | 3 | 1 |
| Nuvasive, Inc. | 4 | 0 |
| Triage Medical, Inc. | 4 | 0 |
| Globus Medical, Inc. | 3 | 0 |
| Sc Medica | 3 | 0 |
| Alphatec Spine, Inc. | 2 | 0 |
| Amendia, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 22, 2010 | K101765 | KYPHON ANCHOR FACET SCREW SYSTEM Medtronic Spine, LLC | MRW |
| Sep 30, 2010 | K102438 | PRIMALOK FACET FIXATION SYSTEM Osteomed LP | MRW |
| Aug 16, 2010 | K101364 | LANX FACET SCREW SYSTEM Lanx, Inc. | MRW |
| Jul 15, 2010 | K101284 | FACET SCREW SYSTEM Nuvasive, Inc. | MRW |
| May 21, 2010 | K100154 | FIXCET SPINAL FACET SCREW SYSTEM X-Spine Systems, Inc. | MRW |
| Nov 17, 2009 | K092568 | SPARTAN S3 FACET SYSTEM Amendia, Inc. | MRW |
| Nov 9, 2009 | K092464 | SPINEOLOGY FACET SCREW Spineology, Inc. | MRW |
| Jul 14, 2009 | K090952 | ZYFUSE FACET FIXATION SYSTEM Globus Medical, Inc. | MRW |
| Jun 26, 2009 | K090865 | LIFE SPINE FACET SCREW SPINAL SYSTEM Life Spine | MRW |
| Jun 11, 2009 | K090767 | PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER Interventional Spine, Inc. | MRW |
| Feb 6, 2009 | K083442 | CORRIDOR FIXATION SYSTEM Globus Medical, Inc. | MRW |
| Dec 12, 2008 | K082795 | SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT Interventional Spine, Inc. | MRW |
| Mar 11, 2008 | K073515 | TRANS1 FACET SCREW Trans1 Incorporated | MRW |
| Jan 16, 2008 | K071420 | CHAMELEON FIXATION SYSTEM Spinefrontier, Inc. | MRW |
| Sep 14, 2006 | K062391 | DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00 Triage Medical, Inc. | MRW |
| Jun 19, 2006 | K061041 | US SPINE FACET FIXATION SYSTEM Us Spine | MRW |
| Oct 17, 2005 | K052043 | 3.8MM CS FACET COMPRESSION DEVICE Triage Medical, Inc. | MRW |
| Sep 26, 2005 | K051856 | TRANS1 FACET SCREWS Trans1 Incorporated | MRW |
| Aug 5, 2005 | K051949 | 4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040 Triage Medical, Inc. | MRW |
| Feb 18, 2005 | K043351 | 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N Triage Medical, Inc. | MRW |
| Aug 22, 2003 | K031657 | STRYKER SPINE OASYS BONE SCREW Howmedica Osteonics Corp. | MRW |
| Jul 24, 2002 | K021705 | MODIFICATION TO TOWNLEY TRANSFACEPEDICULAR SCREW FIXATION SYSTEM Medtronic Sofamor Danek, Inc. | MRW |
| Mar 12, 2002 | K020411 | NUVASIVE TRIAD FACET SCREW SYSTEM Nuvasive, Inc. | MRW |
| Dec 19, 2001 | K013829 | MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM Medtronic Sofamor Danek, Inc. | MRW |
| Nov 16, 2001 | K012773 | DISCOVERY FACET SCREW FIXATION SYSTEM Depuyacromed | MRW |
| Jan 17, 2001 | K003928 | TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM Medtronic Sofamor Danek, Inc. | MRW |
| Jul 25, 2000 | K001323 | NUVASIVE PERCUTANEOUS TRANSFACET/INTRAPEDICULAR SCREW Nuvasive, Inc. | MRW |
| Apr 18, 2000 | K994308 | NUVASIVE TOWNLEY FACET SCREW Nuvasive, Inc. | MRW |
| Feb 28, 1997 | K953076 | TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM Sofamor Danek USA,Inc. | MRW |
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