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 |
|---|---|---|---|
| Aug 6, 2015 | K151374 | NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System Nu Vasive, Incorporated | MAX |
| Aug 6, 2015 | K151128 | CAPSTONE Spinal System, CLYDESDALE Spinal System Medtronic Sofamor Danek USA, Inc. | MAX |
| Jul 31, 2015 | K151483 | Biomet Spine Fusion System Biomet Spine, LLC | MAX |
| Jul 22, 2015 | K151020 | Rampart-T Interbody Fusion System Spineology, Inc. | MAX |
| Jul 22, 2015 | K143143 | PATHWAY ELIF Custom Spine, Inc. | MAX |
| Jul 17, 2015 | K151654 | PROW FUSION Nlt Spine, Ltd., IL | MAX |
| Jul 14, 2015 | K151184 | InFill Interbody Fusion Devices Pinnacle Spine Group, LLC | MAX |
| Jul 13, 2015 | K150321 | EVOS Lumbar Interbody System Cutting Edge Spine, LLC | MAX |
| Jul 9, 2015 | K151581 | Leva Spacer System Spine Wave, Inc. | MAX |
| Jul 9, 2015 | K151143 | EndoLIF On-Cage Joimax GmbH, DE | MAX |
| Jun 19, 2015 | K150500 | Px PEEK IBF System Innovasis, Inc. | MAX |
| Jun 18, 2015 | K151276 | DePuy Synthes T-PAL Ti Spacer Synthes USA Products, LLC | MAX |
| Jun 11, 2015 | K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion System Medtronic Sofamor Danek USA, Inc. | MAX |
| Jun 9, 2015 | K142559 | ELEVATE Spinal System Medtronic Sofamor Danek USA, Inc. | MAX |
| May 22, 2015 | K143740 | Battalion Universal Spacer System Alphatec Spine, Inc. | MAX |
| May 19, 2015 | K150061 | Lucent; Lucent Ti-Bond Systems Spinal Elements, Inc. | MAX |
| May 13, 2015 | K142504 | SpineFrontier Lumbar Interbody Fusion Device System Spinefrontier, Inc. | MAX |
| May 11, 2015 | K150152 | The Octane Straight Intervertebral Fusion Device, Ti Coated Exactech, Inc. | MAX |
| May 7, 2015 | K150954 | Elite L Expandable Lumbar Fusion System Innova Spinal Technologies, LLC | MAX |
| Apr 29, 2015 | K143595 | NuVasive(R) CCX-L Interbody System Nu Vasive, Incorporated | MAX |
| Apr 29, 2015 | K142392 | Zavation Posterior LEIF Zavation, LLC | MAX |
| Apr 23, 2015 | K140348 | INTERBODY CAGE Eisertech, LLC | MAX |
| Apr 9, 2015 | K143258 | PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) 4Web, Inc. | MAX |
| Apr 3, 2015 | K150206 | InFill Interbody Fusion Devices Pinnacle Spine Group, LLC | MAX |
| Mar 20, 2015 | K143158 | Xenco Medical Lumbar Interbody System Xenco Medical, LLC | MAX |
| Mar 13, 2015 | K141665 | NuVasive CoRoent System Nuvasive, Inc. | MAX |
| Mar 12, 2015 | K142634 | Biomet Spine Fusion System Biomet Spine, LLC | MAX |
| Mar 5, 2015 | K150285 | Leva(TM) Spacer System Spine Wave, Inc. | MAX |
| Mar 5, 2015 | K143616 | AccuLIF TL and PL Cage Stryker Corporation | MAX |
| Feb 12, 2015 | K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lum Zimmer Spine, Inc. | MAX |
| Feb 6, 2015 | K143126 | Renovis S141 Lumbar Interbody Cage System Renovis Surgical Technologies | MAX |
| Jan 26, 2015 | K141980 | LEVA (TM) SPACER SYSTEM Spine Wave, Inc. | MAX |
| Dec 18, 2014 | K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMeta Seaspine, Inc. | MAX |
| Dec 1, 2014 | K141135 | JULIET LL Spineart, CH | MAX |
| Nov 28, 2014 | K142594 | nva, nvp, nvt Nvision Biomedical Technologies, LLC | MAX |
| Nov 24, 2014 | K140716 | OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE Interventional Spine, Inc. | MAX |
| Nov 20, 2014 | K142023 | LUNA INTERBODY SYSTEM Benvenue Medical, Inc. | MAX |
| Nov 20, 2014 | K141896 | COROENT SYSTEM Nu Vasive, Incorporated | MAX |
| Nov 18, 2014 | K142347 | Amedica Valeo II Interbody Fusion Device Amedica Corp. | MAX |
| Oct 27, 2014 | K141953 | ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL Titan Spine, LLC | MAX |
| Oct 23, 2014 | K142101 | ABACUS (TM) SPACER SYSTEM Spine Wave, Inc. | MAX |
| Oct 17, 2014 | K142589 | Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton T Titan Spine, LLC | MAX |
| Oct 15, 2014 | K142193 | COGENT MED-LIF XL Cogent Spine, LLC | MAX |
| Oct 14, 2014 | K142277 | JULIET PO Spineart, CH | MAX |
| Oct 9, 2014 | K140319 | COROENT TI-C SYSTEM Nuvasive, Inc. | MAX |
| Oct 1, 2014 | K140577 | INNESIS PEEK TL CAGE Bk Meditech, Co., Ltd. | MAX |
| Sep 26, 2014 | K133577 | CLYDESDALE(R) SPINAL SYSTEM Medtronic Sofamor Danek USA, Inc. | MAX |
| Sep 23, 2014 | K142112 | 4WEB SPINAL IMPLANT PRODUCTS 4Web, Inc. | MAX |
| Sep 19, 2014 | K133717 | LONGBOW SPACER SYSTEM Life Spine | MAX |
| Sep 16, 2014 | K141405 | MOBIS II ST SPINAL IMPLANT Signus Medizintechnik GmbH | MAX |
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