FDA Product Code
FDA Product Code MAX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3080
510(k) Clearances — 896 records · page 6 of 9
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K153436 | LATERAL Spine Truss System | 4Web, Inc. | 2016-06-06 | Traditional | PDF ↗ |
| K160463 | Reliance Lumbar IBF System | Reliance Medical Systems, LLC | 2016-05-20 | Special | PDF ↗ |
| K153107 | Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine VEO Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System | Choicespine, LP | 2016-05-19 | Special | PDF ↗ |
| K153615 | NeoFuse HA Enhanced PLIF/TLIF | Ht Medical, LLC | 2016-05-06 | Traditional | PDF ↗ |
| K153783 | SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF | Spinevision S.A. | 2016-05-04 | Traditional | PDF ↗ |
| K153123 | Genesys Spine Apache Interbody Fusion System | Genesys Spine | 2016-04-26 | Traditional | PDF ↗ |
| K153222 | Leva Spacer System | Spine Wave, Inc. | 2016-04-15 | Traditional | PDF ↗ |
| K153419 | NuVasive CoRoent Thoracolumbar System | Nu Vasive, Incorporated | 2016-04-13 | Traditional | PDF ↗ |
| K143578 | SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer | Globus Medical, Inc. | 2016-04-13 | Traditional | PDF ↗ |
| K160464 | Opticage(R) Expandable Interbody Fusion Device | Interventional Spine, Inc. | 2016-04-04 | Special | PDF ↗ |
| K153495 | Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System | Ldr Spine USA | 2016-03-31 | Traditional | PDF ↗ |
| K152200 | SurgTech Interbody System | Surgtech, Inc. | 2016-03-25 | Traditional | PDF ↗ |
| K160547 | Cascadia Interbody System | K2m | 2016-03-24 | Special | PDF ↗ |
| K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016-03-24 | Traditional | PDF ↗ |
| K153627 | NuVasive® TLX Interbody System | Nu Vasive, Incorporated | 2016-03-17 | Traditional | PDF ↗ |
| K151665 | SUSTAIN Additional Implants | Globus Medical, Inc. | 2016-03-16 | Traditional | PDF ↗ |
| K153400 | ProLift Expandable System | Life Spine, Inc. | 2016-03-07 | Traditional | PDF ↗ |
| K160418 | PERIMETER Interbody Fusion Device | Medtronic Sofamor Danek USA, Inc. | 2016-03-07 | Special | PDF ↗ |
| K151406 | Cogent Lateral Interbody System | Cogent Spine, LLC | 2016-02-25 | Traditional | PDF ↗ |
| K152539 | SpineView X-Pac Expandable Lumbar Cage System | Spine View, Inc. | 2016-02-24 | Traditional | PDF ↗ |
| K153082 | Rampart A Lumbar Interbody Fusion Device | Spineology, Inc. | 2016-02-04 | Traditional | PDF ↗ |
| K152512 | Half Dome Posterior Lumbar Interbody System | Astura Medical | 2016-01-28 | Traditional | PDF ↗ |
| K153695 | Biomet Spine Fusion System | Biomet Spine, LLC | 2016-01-21 | Special | PDF ↗ |
| K151726 | AVS AL and AVS ALign PEEK Spacers, AVS PL and AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer | Stryker Corporation | 2016-01-20 | Traditional | PDF ↗ |
| K152620 | Spine Wave Gen II Expandable Interbody System | Spine Wave, Inc. | 2016-01-15 | Traditional | PDF ↗ |
| K153356 | Spine Innovation Interbody System | Spine Innovation, LLC | 2016-01-14 | Traditional | PDF ↗ |
| K152475 | FORZA PTC Spacer System | Orthofix, Inc. | 2016-01-14 | Traditional | PDF ↗ |
| K151310 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016-01-06 | Traditional | PDF ↗ |
| K152651 | AccuLIF TL and PL Cage | Stryker Corporation | 2015-12-15 | Traditional | PDF ↗ |
| K151900 | VariLift-L Interbody Fusion Device | Wenzel Spine, Inc. | 2015-12-11 | Traditional | PDF ↗ |
| K152355 | Twin Peaks Lumbar Interbody Fusion System | Spineway | 2015-12-10 | Traditional | PDF ↗ |
| K151773 | CONCORDE Bullet Lumbar Interbody System | Medos International SARL | 2015-11-20 | Traditional | PDF ↗ |
| K152304 | Tritanium PL Cage | Stryker | 2015-11-19 | Traditional | PDF ↗ |
| K152259 | InFill Interbody Fusion Device | Pinnacle Spine Group, LLC | 2015-11-19 | Traditional | PDF ↗ |
| K152277 | PIVOX(tm) Oblique Lateral Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015-11-13 | Traditional | PDF ↗ |
| K151819 | Integrity Spine Lumbar Interbody Fusion System | Integrity Spine Lumbar Interbody Fusion System | 2015-11-10 | Traditional | PDF ↗ |
| K152156 | Opticage Expandable Interbody Fusion Device | Interventional Spine, Inc. | 2015-10-19 | Traditional | PDF ↗ |
| K151785 | Px HA PEEK IBF System | Innovasis, Inc. | 2015-10-14 | Traditional | PDF ↗ |
| K151352 | CONCORDE Bullet Spinal System | Medos International SARL | 2015-10-08 | Special | PDF ↗ |
| K143518 | Valeo Spacer System and Valeo II Interbody Fusion Device System | Amedica Corp. | 2015-10-02 | Traditional | PDF ↗ |
| K151408 | LOSPA IS Spinal System | Corentec Co., Ltd. | 2015-10-02 | Traditional | PDF ↗ |
| K143479 | Bluefin Interbody System | Tides Medical | 2015-09-25 | Traditional | PDF ↗ |
| K151322 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2015-09-10 | Traditional | PDF ↗ |
| K151472 | NuVasive CoRoent Lumbar System | Nu Vasive, Incorporated | 2015-09-10 | Traditional | PDF ↗ |
| K151756 | STERISPINE LC CAGE | Safe Orthopaedics | 2015-08-21 | Traditional | PDF ↗ |
| K150481 | Cascadia Interbody System | K2m, Inc. | 2015-08-20 | Traditional | PDF ↗ |
| K151140 | LnK Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2015-08-18 | Special | PDF ↗ |
| K151056 | Aesculap T-Space PEEK and XP Spinal System | Aesculap Implant Systems, LLC | 2015-08-13 | Traditional | PDF ↗ |
| K150395 | Omega LIF System | Amendia, Inc. | 2015-08-10 | Traditional | PDF ↗ |
| K151374 | NuVasive MLX-Medial Lateral Expandable Lumbar Interbody System, NuVasive AP Expandable XLIF System | Nu Vasive, Incorporated | 2015-08-06 | Traditional | PDF ↗ |
| K151128 | CAPSTONE Spinal System, CLYDESDALE Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015-08-06 | Traditional | PDF ↗ |
| K151483 | Biomet Spine Fusion System | Biomet Spine, LLC | 2015-07-31 | Traditional | PDF ↗ |
| K151020 | Rampart-T Interbody Fusion System | Spineology, Inc. | 2015-07-22 | Special | PDF ↗ |
| K143143 | PATHWAY ELIF | Custom Spine, Inc. | 2015-07-22 | Traditional | PDF ↗ |
| K151654 | PROW FUSION | Nlt Spine, Ltd. | 2015-07-17 | Special | PDF ↗ |
| K151184 | InFill Interbody Fusion Devices | Pinnacle Spine Group, LLC | 2015-07-14 | Traditional | PDF ↗ |
| K150321 | EVOS Lumbar Interbody System | Cutting Edge Spine, LLC | 2015-07-13 | Traditional | PDF ↗ |
| K151581 | Leva Spacer System | Spine Wave, Inc. | 2015-07-09 | Special | PDF ↗ |
| K151143 | EndoLIF On-Cage | Joimax GmbH | 2015-07-09 | Traditional | PDF ↗ |
| K150500 | Px PEEK IBF System | Innovasis, Inc. | 2015-06-19 | Traditional | PDF ↗ |
| K151276 | DePuy Synthes T-PAL Ti Spacer | Synthes USA Products, LLC | 2015-06-18 | Special | PDF ↗ |
| K150135 | DIVERGENCE-L Anterior/Oblique Lumbar Fusion System | Medtronic Sofamor Danek USA, Inc. | 2015-06-11 | Traditional | PDF ↗ |
| K142559 | ELEVATE Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015-06-09 | Traditional | PDF ↗ |
| K143740 | Battalion Universal Spacer System | Alphatec Spine, Inc. | 2015-05-22 | Traditional | PDF ↗ |
| K150061 | Lucent; Lucent Ti-Bond Systems | Spinal Elements, Inc. | 2015-05-19 | Traditional | PDF ↗ |
| K142504 | SpineFrontier Lumbar Interbody Fusion Device System | Spinefrontier, Inc. | 2015-05-13 | Traditional | PDF ↗ |
| K150152 | The Octane Straight Intervertebral Fusion Device, Ti Coated | Exactech, Inc. | 2015-05-11 | Traditional | PDF ↗ |
| K150954 | Elite L Expandable Lumbar Fusion System | Innova Spinal Technologies, LLC | 2015-05-07 | Special | PDF ↗ |
| K143595 | NuVasive(R) CCX-L Interbody System | Nu Vasive, Incorporated | 2015-04-29 | Traditional | PDF ↗ |
| K142392 | Zavation Posterior LEIF | Zavation, LLC | 2015-04-29 | Traditional | PDF ↗ |
| K140348 | INTERBODY CAGE | Eisertech, LLC | 2015-04-23 | Traditional | PDF ↗ |
| K143258 | PLIF STS, TLIF STS, OLIF STS (Spinal Truss System) | 4Web, Inc. | 2015-04-09 | Traditional | PDF ↗ |
| K150206 | InFill Interbody Fusion Devices | Pinnacle Spine Group, LLC | 2015-04-03 | Special | PDF ↗ |
| K143158 | Xenco Medical Lumbar Interbody System | Xenco Medical, LLC | 2015-03-20 | Traditional | PDF ↗ |
| K141665 | NuVasive CoRoent System | Nuvasive, Inc. | 2015-03-13 | Traditional | PDF ↗ |
| K142634 | Biomet Spine Fusion System | Biomet Spine, LLC | 2015-03-12 | Traditional | PDF ↗ |
| K150285 | Leva(TM) Spacer System | Spine Wave, Inc. | 2015-03-05 | Special | PDF ↗ |
| K143616 | AccuLIF TL and PL Cage | Stryker Corporation | 2015-03-05 | Traditional | PDF ↗ |
| K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) | Zimmer Spine, Inc. | 2015-02-12 | Traditional | PDF ↗ |
| K143126 | Renovis S141 Lumbar Interbody Cage System | Renovis Surgical Technologies | 2015-02-06 | Traditional | PDF ↗ |
| K141980 | LEVA (TM) SPACER SYSTEM | Spine Wave, Inc. | 2015-01-26 | Traditional | PDF ↗ |
| K142488 | SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene | Seaspine, Inc. | 2014-12-18 | Traditional | PDF ↗ |
| K141135 | JULIET LL | Spineart | 2014-12-01 | Traditional | PDF ↗ |
| K142594 | nva, nvp, nvt | Nvision Biomedical Technologies, LLC | 2014-11-28 | Traditional | PDF ↗ |
| K140716 | OPTICAGE EXPANDABLE INTERBODY FUSION DEVICE | Interventional Spine, Inc. | 2014-11-24 | Traditional | PDF ↗ |
| K141896 | COROENT SYSTEM | Nu Vasive, Incorporated | 2014-11-20 | Traditional | PDF ↗ |
| K142023 | LUNA INTERBODY SYSTEM | Benvenue Medical, Inc. | 2014-11-20 | Traditional | PDF ↗ |
| K142347 | Amedica Valeo II Interbody Fusion Device | Amedica Corp. | 2014-11-18 | Traditional | PDF ↗ |
| K141953 | ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL | Titan Spine, LLC | 2014-10-27 | Traditional | PDF ↗ |
| K142101 | ABACUS (TM) SPACER SYSTEM | Spine Wave, Inc. | 2014-10-23 | Traditional | PDF ↗ |
| K142589 | Endoskeleton TA IBD and VBR, Endoskeleton TO and TT, Endoskeleton TAS, Endoskeleton TAS, Endoskeleton TC, Endoskeleton TL | Titan Spine, LLC | 2014-10-17 | Special | PDF ↗ |
| K142193 | COGENT MED-LIF XL | Cogent Spine, LLC | 2014-10-15 | Special | PDF ↗ |
| K142277 | JULIET PO | Spineart | 2014-10-14 | Traditional | PDF ↗ |
| K140319 | COROENT TI-C SYSTEM | Nuvasive, Inc. | 2014-10-09 | Traditional | PDF ↗ |
| K140577 | INNESIS PEEK TL CAGE | Bk Meditech, Co., Ltd. | 2014-10-01 | Traditional | PDF ↗ |
| K133577 | CLYDESDALE(R) SPINAL SYSTEM | Medtronic Sofamor Danek USA, Inc. | 2014-09-26 | Traditional | PDF ↗ |
| K142112 | 4WEB SPINAL IMPLANT PRODUCTS | 4Web, Inc. | 2014-09-23 | Special | PDF ↗ |
| K133717 | LONGBOW SPACER SYSTEM | Life Spine | 2014-09-19 | Traditional | PDF ↗ |
| K141405 | MOBIS II ST SPINAL IMPLANT | Signus Medizintechnik GmbH | 2014-09-16 | Traditional | PDF ↗ |
| K141443 | INFRONT LUMBAR INTERBODY FUSION SYSTEM | Infront Medical, LLC | 2014-08-28 | Traditional | PDF ↗ |
Product code MAX · Class II · Orthopedic. Data: openFDA.