Panels › Orthopedic › Product code MAX · Class 2
Intervertebral Fusion Device With Bone Graft, Lumbar
Regulation 888.3080
20510(k)s in 12 months (897 all time)
5recalls in 12 months (116 all time)
105recalls that name a 510(k)
Top companies in MAX
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 55 | 12 |
| Globus Medical, Inc. | 20 | 22 |
| Nu Vasive, Incorporated | 34 | 0 |
| Life Spine | 33 | 0 |
| Alphatec Spine | 22 | 3 |
| Spineology, Inc. | 22 | 0 |
| SeaSpine Orthopedics Corporation | 20 | 1 |
| Spinal Elements | 17 | 2 |
| Stryker | 17 | 0 |
| K2m | 13 | 3 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 27, 2009 | K083661 | AVS TL PEEK SPACERS Stryker Corp. | MAX |
| Feb 6, 2009 | K081888 | DYNAMIK INTERVERTEBRAL BODY FUSION DEVICE Spineart, CH | MAX |
| Feb 2, 2009 | K082262 | LDR SPINE ROI INTERBODY FUSION SYSTEM Ldr Spine USA | MAX |
| Jan 14, 2009 | K082406 | EXPANDABLE PEEK-OPTIMA IMPLANT Ebi, L.P. | MAX |
| Jan 2, 2009 | K082712 | THEKEN SPINE VU EPOD AND VU LPOD SYSTEM Theken Spine, LLC | MAX |
| Dec 29, 2008 | K083026 | CLYDESDALE SPINAL SYSTEM Medtronic Sofamor Danek | MAX |
| Nov 14, 2008 | K082128 | DEPUY SPINE LATERAL CAGE SYSTEM Depuy Spine | MAX |
| Nov 14, 2008 | K081673 | DYN-ALIF ANTEROLATERAL INTERVERTEBRAL BODY FUSION DEVICE Ionics Medical Corp. | MAX |
| Nov 10, 2008 | K082310 | HOLLYWOOD, PACIFICA, REDONDO, VENTURA Seaspine, Inc. | MAX |
| Oct 21, 2008 | K082774 | LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE Lanx, LLC | MAX |
| Oct 17, 2008 | K082260 | INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES Calvary Spine, LLC | MAX |
| Oct 16, 2008 | K082732 | MODIFICATION TO: CAPSTONE SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. | MAX |
| Oct 16, 2008 | K081196 | SPINAL USA VBR SYSTEM Spinal USA | MAX |
| Sep 16, 2008 | K082270 | OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM Vertiflex, Inc. | MAX |
| Sep 12, 2008 | K082342 | MODIFICATION TO CAPSTONE SPINAL SYSTEM Medtronic Sofamor Danek | MAX |
| Sep 4, 2008 | K082235 | BLACKSTONE PILLAR XL PEEK SPACERS Blackstone Medical, Inc. | MAX |
| Aug 7, 2008 | K081636 | PEEK-OPTIMA ALIF SPACER Biomet Spine | MAX |
| Aug 5, 2008 | K081968 | MODIFICATION TO LUCENT Spinal Elements, Inc. | MAX |
| Jul 28, 2008 | K082014 | STRYKER SPINE AVS PL PEEK SPACERS Stryker Corp. | MAX |
| Jul 23, 2008 | K081177 | BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM Blackstone Medical, Inc. | MAX |
| Jun 30, 2008 | K080537 | L-VARLOCK Kiscomedica S.A. | MAX |
| Jun 17, 2008 | K080615 | ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD) Titan Spine, LLC | MAX |
| Jun 10, 2008 | K080673 | INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE Vertebral Technologies, Inc. | MAX |
| May 30, 2008 | K080588 | SCIENT'X TRIBECA VBR Scient'X USA, Inc. | MAX |
| May 15, 2008 | K080411 | PLATEAU SPACER SYSTEM Life Spine | MAX |
| May 13, 2008 | K080314 | SPINAL USA INTERBODY FUSION DEVICE Spinal USA | MAX |
| May 13, 2008 | K073177 | PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM Pioneer Surgical Technology | MAX |
| May 9, 2008 | K080401 | SHELL CAGE, WAVE CAGE, LOOP CAGE Advanced Medical Technologies AG | MAX |
| May 1, 2008 | K080281 | PATHWAY Custom Spine, Inc. | MAX |
| May 1, 2008 | K071983 | AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE Aesculap Implant Systems, Inc. | MAX |
| Apr 24, 2008 | K073440 | FOUNDATION CAGE Corelink, LLC | MAX |
| Apr 24, 2008 | K073291 | CAPSTONE SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. | MAX |
| Apr 16, 2008 | K080058 | TURBO PRIME IBD SYSTEM Spineselect, LLC | MAX |
| Apr 10, 2008 | K080083 | INTREPID SPINAL SYSTEM Medtronic Sofamor Danek | MAX |
| Mar 27, 2008 | K080758 | AVS PL PEEK SPACERS, MODELS 48351 AND 48353 Stryker Corp. | MAX |
| Mar 6, 2008 | K073470 | AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX Stryker Spine | MAX |
| Feb 13, 2008 | K073669 | ORIA NATURA SPACER Choicespine, LP | MAX |
| Jan 30, 2008 | K073202 | ARDIS SPACER Abbott Spine, Inc. | MAX |
| Jan 24, 2008 | K073144 | LANX INTERVERTEBRAL BODY FUSION DEVICE Lanx, LLC | MAX |
| Jan 18, 2008 | K072970 | PATRIOT SPACERS Globus Medical, Inc. | MAX |
| Dec 26, 2007 | K073348 | LUCENT MAGNUM Spinal Elements, Inc. | MAX |
| Dec 26, 2007 | K072791 | ORACLE SPACER, OPAL SPACER Synthes Spine | MAX |
| Dec 10, 2007 | K072226 | IMPIX SPACER Medicrea Technologies | MAX |
| Dec 4, 2007 | K071795 | NUVASIVE COROENT SYSTEM Nuvasive, Inc. | MAX |
| Nov 9, 2007 | K071724 | LUCENT Spinal Elements, Inc. | MAX |
| Nov 1, 2007 | K072289 | SPINEFRONTIER DORADO VBR Spinefrontier, Inc. | MAX |
| Oct 11, 2007 | K072120 | PARAMOUNT INTERVERTEBRAL BODY FUSION DEVICE Innovative Spinal Technologies, Inc. | MAX |
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