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 |
|---|---|---|---|
| Jun 9, 2016 | K152011 | Lucent Intervertebral Body Fusion Device Spinal Elements, Inc. | MAX |
| Jun 6, 2016 | K153436 | LATERAL Spine Truss System 4Web, Inc. | MAX |
| May 20, 2016 | K160463 | Reliance Lumbar IBF System Reliance Medical Systems, LLC | MAX |
| May 19, 2016 | K153107 | Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine VEO Lateral Access & Interbody Fusi Choicespine, LP | MAX |
| May 6, 2016 | K153615 | NeoFuse HA Enhanced PLIF/TLIF Ht Medical, LLC | MAX |
| May 4, 2016 | K153783 | SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF Spinevision S.A., FR | MAX |
| Apr 26, 2016 | K153123 | Genesys Spine Apache Interbody Fusion System Genesys Spine | MAX |
| Apr 15, 2016 | K153222 | Leva Spacer System Spine Wave, Inc. | MAX |
| Apr 13, 2016 | K153419 | NuVasive CoRoent Thoracolumbar System Nu Vasive, Incorporated | MAX |
| Apr 13, 2016 | K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY Globus Medical, Inc. | MAX |
| Apr 4, 2016 | K160464 | Opticage(R) Expandable Interbody Fusion Device Interventional Spine, Inc. | MAX |
| Mar 31, 2016 | K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System Ldr Spine USA | MAX |
| Mar 25, 2016 | K152200 | SurgTech Interbody System Surgtech, Inc. | MAX |
| Mar 24, 2016 | K160547 | Cascadia Interbody System K2m | MAX |
| Mar 24, 2016 | K153782 | NuVasive® Lumbar Interbody Implants Nu Vasive, Incorporated | MAX |
| Mar 17, 2016 | K153627 | NuVasive® TLX Interbody System Nu Vasive, Incorporated | MAX |
| Mar 16, 2016 | K151665 | SUSTAIN Additional Implants Globus Medical, Inc. | MAX |
| Mar 7, 2016 | K160418 | PERIMETER Interbody Fusion Device Medtronic Sofamor Danek USA, Inc. | MAX |
| Mar 7, 2016 | K153400 | ProLift Expandable System Life Spine, Inc. | MAX |
| Feb 25, 2016 | K151406 | Cogent Lateral Interbody System Cogent Spine, LLC | MAX |
| Feb 24, 2016 | K152539 | SpineView X-Pac Expandable Lumbar Cage System Spine View, Inc. | MAX |
| Feb 4, 2016 | K153082 | Rampart A Lumbar Interbody Fusion Device Spineology, Inc. | MAX |
| Jan 28, 2016 | K152512 | Half Dome Posterior Lumbar Interbody System Astura Medical | MAX |
| Jan 21, 2016 | K153695 | Biomet Spine Fusion System Biomet Spine, LLC | MAX |
| Jan 20, 2016 | K151726 | AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, A Stryker Corporation | MAX |
| Jan 15, 2016 | K152620 | Spine Wave Gen II Expandable Interbody System Spine Wave, Inc. | MAX |
| Jan 14, 2016 | K153356 | Spine Innovation Interbody System Spine Innovation, LLC | MAX |
| Jan 14, 2016 | K152475 | FORZA PTC Spacer System Orthofix, Inc. | MAX |
| Jan 6, 2016 | K151310 | Amendia Interbody Fusion Devices Amendia, Inc. | MAX |
| Dec 15, 2015 | K152651 | AccuLIF TL and PL Cage Stryker Corporation | MAX |
| Dec 11, 2015 | K151900 | VariLift-L Interbody Fusion Device Wenzel Spine, Inc. | MAX |
| Dec 10, 2015 | K152355 | Twin Peaks Lumbar Interbody Fusion System Spineway, FR | MAX |
| Nov 20, 2015 | K151773 | CONCORDE Bullet Lumbar Interbody System Medos International SARL, CH | MAX |
| Nov 19, 2015 | K152304 | Tritanium PL Cage Stryker | MAX |
| Nov 19, 2015 | K152259 | InFill Interbody Fusion Device Pinnacle Spine Group, LLC | MAX |
| Nov 13, 2015 | K152277 | PIVOX(tm) Oblique Lateral Spinal System Medtronic Sofamor Danek USA, Inc. | MAX |
| Nov 10, 2015 | K151819 | Integrity Spine Lumbar Interbody Fusion System Integrity Spine Lumbar Interbody Fusion System | MAX |
| Oct 19, 2015 | K152156 | Opticage Expandable Interbody Fusion Device Interventional Spine, Inc. | MAX |
| Oct 14, 2015 | K151785 | Px HA PEEK IBF System Innovasis, Inc. | MAX |
| Oct 8, 2015 | K151352 | CONCORDE Bullet Spinal System Medos International SARL, CH | MAX |
| Oct 2, 2015 | K151408 | LOSPA IS Spinal System Corentec Co., Ltd., KR | MAX |
| Oct 2, 2015 | K143518 | Valeo Spacer System and Valeo II Interbody Fusion Device System Amedica Corp. | MAX |
| Sep 25, 2015 | K143479 | Bluefin Interbody System Tides Medical | MAX |
| Sep 10, 2015 | K151472 | NuVasive CoRoent Lumbar System Nu Vasive, Incorporated | MAX |
| Sep 10, 2015 | K151322 | Amendia Interbody Fusion Devices Amendia, Inc. | MAX |
| Aug 21, 2015 | K151756 | STERISPINE LC CAGE Safe Orthopaedics, FR | MAX |
| Aug 20, 2015 | K150481 | Cascadia Interbody System K2m, Inc. | MAX |
| Aug 18, 2015 | K151140 | LnK Lumbar Interbody Fusion Cage System L&K BIOMED Co., Ltd., KR | MAX |
| Aug 13, 2015 | K151056 | Aesculap T-Space PEEK and XP Spinal System Aesculap Implant Systems, LLC | MAX |
| Aug 10, 2015 | K150395 | Omega LIF System Amendia, Inc. | MAX |
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