Panels › Orthopedic › Product code OVD · Class 2
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Regulation 888.3080
9510(k)s in 12 months (205 all time)
2recalls in 12 months (36 all time)
36recalls that name a 510(k)
Top companies in OVD
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 11, 2014 | K132596 | PROPOSED OPTIMUS Custom Spine, Inc. | OVD |
| Mar 27, 2014 | K140106 | S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM Renovis Surgical Technologies, Inc. | OVD |
| Jan 9, 2014 | K133286 | MIDLINE (TM) Centinel Spine, Inc. | OVD |
| Jan 6, 2014 | K131276 | LATERAL SYNFIX Synthes (USA) Products, LLC | OVD |
| Dec 30, 2013 | K132559 | MONUMENT SPACERS Globus Medical, Inc. | OVD |
| Sep 20, 2013 | K131723 | COROENT SINGLE TAB SYSTEM Nuvasive, Inc. | OVD |
| Sep 18, 2013 | K131122 | S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM Renovis Surgical Technologies, LLC | OVD |
| Sep 13, 2013 | K130641 | LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE Binder Biomedical, Inc. | OVD |
| Aug 28, 2013 | K130461 | STALIF X Centinel Spine, Inc. | OVD |
| Jul 12, 2013 | K131547 | LANX FUSION SYSTEM Lanx, Inc. | OVD |
| May 17, 2013 | K124034 | MECTALIF ANTERIOR Medacta International | OVD |
| Apr 25, 2013 | K130445 | VAULT ALIF SYSTEM Spinal USA | OVD |
| Apr 16, 2013 | K123045 | BRIGADE STANDALONE SYSTEM Nuvasive, Inc. | OVD |
| Mar 18, 2013 | K123767 | LANX FUSION SYSTEM- SA Lanx, Inc. | OVD |
| Mar 5, 2013 | K123993 | SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM Alphatec Spine, Inc. | OVD |
| Nov 1, 2012 | K112700 | FRONTIER SADL INTERBODY FUSION DEVICE Frontier Medical Devices, Inc. | OVD |
| Oct 25, 2012 | K120869 | ANCHOR-L LUMBAR CAGE Stryker Spine | OVD |
| Oct 11, 2012 | K122168 | VISUALIF CHALLENGING ACCESS PLATE Spine Smith Partners L.P. | OVD |
| Jul 26, 2012 | K121982 | SOVEREIGN SPINAL SYSTEM Medtronic Sofamor Danek | OVD |
| Jul 26, 2012 | K113285 | LDR SPINE USA AVENUE L INTERBODY FUSION Ldr Spine USA, Inc. | OVD |
| Jun 27, 2012 | K121211 | VU APOD INTERVERTEBRAL BODY FUSION DEVICE Theken Spine, LLC | OVD |
| Mar 27, 2012 | K120101 | INDEPENDENCE SPACER Globus Medical, Inc. | OVD |
| Mar 19, 2012 | K120557 | SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 Biomet Spine & Bone Healing Technologies | OVD |
| Mar 16, 2012 | K120031 | CHESAPEAKE SPINAL SYSTEM K2m, Inc. | OVD |
| Mar 13, 2012 | K112561 | NUVASIVE COROENT NO-PROFILE SYSTEM Nuvasive, Inc. | OVD |
| Oct 4, 2011 | K110063 | SOVEREIGN SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | OVD |
| Sep 30, 2011 | K110327 | LDR SPINE ROI-A INTERBODY FUSION SYSTEM Ldr Spine USA | OVD |
| Sep 9, 2011 | K111626 | ENDOSKELETON(R) TAS Titan Spine, LLC | OVD |
| Aug 4, 2011 | K111122 | AESCULAP SIBD XP SPINAL SYSTEM Aesculap Implant Systems, Inc. | OVD |
| May 20, 2011 | K103382 | INTERCONTINENTAL PLATE-SPACER Globus Medical, Inc. | OVD |
| Apr 4, 2011 | K103369 | VAULT ALIF SYSTEM Spinal USA | OVD |
| Mar 30, 2011 | K102402 | SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM Alphatec Spine, Inc. | OVD |
| Feb 10, 2011 | K102738 | LANX FUSION SYSTEM Lanx, LLC | OVD |
| Jan 12, 2011 | K102121 | ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR Apollo Spine, Inc. | OVD |
| Dec 3, 2010 | K100516 | ANYPLUS PEEK CAGES GS Medical Co., Ltd. | OVD |
| Sep 30, 2010 | K102090 | SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM Spine Smith Partners L.P. | OVD |
| Sep 2, 2010 | K101310 | VU APOD INTERVERTEBRAL BODY FUSION DEVICE Theken Spine, LLC | OVD |
| Jul 20, 2010 | K100802 | AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM Aesculap Implant Systems, Inc. | OVD |
| Jun 16, 2010 | K100043 | COROENT XLR STANDALONE SYSTEM Nuvasive, Inc. | OVD |
| Mar 24, 2010 | K093808 | INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE Incite Innovation, LLC | OVD |
| Mar 9, 2010 | K093629 | SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM Biomet Spine | OVD |
| Mar 5, 2010 | K092211 | CHESAPEAKE SPINAL SYSTEM K2m, Inc. | OVD |
| Dec 15, 2009 | K091301 | LIFE SPINE STAND-ALONE SPACER SYSTEM Life Spine | OVD |
| Nov 17, 2009 | K091813 | INTREPID SPINAL SYSTEM Medtronic Sofamor Danek | OVD |
| Feb 13, 2009 | K083475 | LUCENT MAGNUM Spinal Elements, Inc. | OVD |
| Dec 22, 2008 | K082926 | ZUMA, MODEL 55-XXXX/56-XXXX Seaspine, Inc. | OVD |
| Nov 5, 2008 | K082252 | INDEPENDENCE SPACER Globus Medical, Inc. | OVD |
| Sep 11, 2008 | K081711 | LUCENT MAGNUM+ Spinal Elements, Inc. | OVD |
| Aug 28, 2008 | K081849 | BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE Blackstone Medical, Inc. | OVD |
| Jul 2, 2008 | K081501 | SOLITAIRE ANTERIOR SPINAL SYSTEM Biomet Spine | OVD |
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