FDA Product Code
FDA Product Code OVD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3080
510(k) Clearances — 205 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System | INNO Holdings Inc. DBA Innovasis | 2026-09-11 | Traditional | PDF ↗ |
| K261408 | SABER-XA System | Elevation Spine | 2026-08-03 | Traditional | PDF ↗ |
| K261809 | Interwedge® Standalone Lateral | Foundation Surgical Group | 2026-07-31 | Special | PDF ↗ |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System | Kyocera Medical Technologies, Inc. | 2026-07-15 | Traditional | PDF ↗ |
| K260810 | Anteralign LS coverplate | Tyber Medical, LLC | 2026-06-10 | Traditional | PDF ↗ |
| K254202 | MectaLIF 3D Metal Anterior | Medacta International S.A. | 2026-05-05 | Traditional | PDF ↗ |
| K253401 | SCRIPT Implant System | Globus Medical, Inc. | 2026-04-29 | Traditional | PDF ↗ |
| K253559 | Ventana A Anterior Lumbar Interbody System | Spinal Elements, Inc. | 2026-02-25 | Traditional | PDF ↗ |
| K251829 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 2025-12-08 | Traditional | PDF ↗ |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System | Alphatec Spine | 2025-09-03 | Traditional | PDF ↗ |
| K250072 | CONDUIT SYNFIX Evolution Secured Spacer System | Avalign Technologies, Inc. | 2025-07-10 | Traditional | PDF ↗ |
| K251644 | ProAM ALIF System | Pro Surgical, Inc. | 2025-06-24 | Special | PDF ↗ |
| K250845 | Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | 2025-06-18 | Traditional | PDF ↗ |
| K251459 | OneLIF Interbody Fusion System | Novapproach Spine, LLC | 2025-06-12 | Special | PDF ↗ |
| K243934 | Stable-L Lumbar Interbody System | Nexus Spine, LLC | 2025-04-30 | Traditional | PDF ↗ |
| K243386 | Ventris Intervertebral Body Fusion Device | Acuity Surgical Devices, LLC | 2025-04-22 | Traditional | PDF ↗ |
| K250603 | AxTiHA® Stand-Alone ALIF System | Innovasis | 2025-03-24 | Special | PDF ↗ |
| K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2025-03-17 | Traditional | PDF ↗ |
| K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2024-12-13 | Special | PDF ↗ |
| K243191 | Atlas Spine Lateral Expandable Interbody System | Atlas Spine, Inc. | 2024-11-26 | Traditional | PDF ↗ |
| K241077 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | 2024-10-29 | Traditional | PDF ↗ |
| K241992 | Catalyft LS Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | 2024-10-28 | Traditional | PDF ↗ |
| K241477 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2024-10-09 | Traditional | PDF ↗ |
| K241487 | Interwedge® Standalone Lateral | Foundation Surgical Group, Inc. | 2024-10-02 | Traditional | PDF ↗ |
| K241321 | Juliet® Ti LL Lumbar Interbody Device | Spineart SA | 2024-07-18 | Traditional | PDF ↗ |
| K240368 | E3D-A Interbody System | Evolution Spine | 2024-05-15 | Traditional | PDF ↗ |
| K240126 | ProAM ALIF System | Pro Surgical, Inc. | 2024-05-03 | Traditional | PDF ↗ |
| K240623 | Omnia Medical TiBrid-SA System | Omnia Medical, LLC | 2024-04-24 | Traditional | PDF ↗ |
| K233966 | Anterior Spine Truss System-Stand Alone (ASTS-SA) | 4Web Medical, Inc. | 2024-04-22 | Traditional | PDF ↗ |
| K232432 | E3D-A Interbody System | Evolution Spine | 2024-01-30 | Traditional | PDF ↗ |
| K232123 | MectaLIF Anterior Lag Extension | Medacta International S.A. | 2023-10-18 | Traditional | PDF ↗ |
| K231486 | Stable-L Standalone Lumbar Interbody System | Nexus Spine, LLC | 2023-10-12 | Traditional | PDF ↗ |
| K232097 | IdentiTi ALIF Interbody Systems | Alphatec Spine, Inc. | 2023-09-25 | Traditional | PDF ↗ |
| K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System | Nexus Spine, LLC | 2023-09-18 | Special | PDF ↗ |
| K232154 | MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation | MiRus, LLC | 2023-09-11 | Traditional | PDF ↗ |
| K230894 | NuVasive Modulus ALIF System | Nu Vasive, Incorporated | 2023-06-16 | Traditional | PDF ↗ |
| K230731 | Zavation ALIF System | Zavation Medical Products, LLC | 2023-06-14 | Traditional | PDF ↗ |
| K230808 | PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System | Kyocera Medical Technologies, Inc. | 2023-04-21 | Special | PDF ↗ |
| K221324 | ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) | Camber Spine Technologies | 2023-03-30 | Traditional | PDF ↗ |
| K223413 | Pisces-SA STANDALONE ALIF Interbody System | Osseus Fusion Systems | 2023-02-10 | Traditional | PDF ↗ |
| K223146 | EVOLUTION SPINE Interbody System | Evolution Spine | 2023-02-07 | Traditional | PDF ↗ |
| K222554 | EL CAPITAN Anterior Lumbar Interbody Fusion | Astura Medical | 2023-01-19 | Traditional | PDF ↗ |
| K222009 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2022-11-22 | Traditional | PDF ↗ |
| K221545 | MectaLIF Anterior Extension | Medacta International S.A. | 2022-10-24 | Traditional | PDF ↗ |
| K221751 | NuVasive Cohere ALIF System Intervertebral Body Fusion Device | Nu Vasive, Incorporated | 2022-10-21 | Traditional | PDF ↗ |
| K221936 | Standalone ALIF Interbody Fusion System | Eminent Spine | 2022-10-17 | Traditional | PDF ↗ |
| K221447 | Southern Anterior Screw Fixated Cage (SASCA) | Southern Medical (Pty) , Ltd. | 2022-10-14 | Traditional | PDF ↗ |
| K222561 | Align | Acuity Surgical Devices, LLC | 2022-09-23 | Special | PDF ↗ |
| K220610 | SOLO-L | Aurora Spine, Inc. | 2022-05-27 | Traditional | PDF ↗ |
| K220115 | ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System | MiRus, LLC | 2022-05-13 | Traditional | PDF ↗ |
| K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022-05-06 | Traditional | PDF ↗ |
| K211837 | Altus Spine Interbody Standalone Fusion System | Altus Partners, LLC | 2022-04-19 | Traditional | PDF ↗ |
| K213118 | Dakota ALIF System | Precision Spine, Inc. | 2022-04-01 | Traditional | PDF ↗ |
| K214047 | EL CAPITAN Anterior Lumbar Interbody Fusion System | Astura Medical | 2022-03-30 | Traditional | PDF ↗ |
| K212498 | Stable-L Standalone Lumbar Interbody System | Nexus Spine, LLC | 2022-03-18 | Traditional | PDF ↗ |
| K212980 | Tesera-k ALIF System | Kyocera Medical Technologies, Inc. | 2022-01-07 | Traditional | PDF ↗ |
| K212967 | AxTiHA Stand-Alone ALIF System | Innovasis, Inc. | 2021-10-15 | Special | PDF ↗ |
| K210590 | Axis Spine Technologies ALIF | Axis Spine Technologies, Ltd. | 2021-09-29 | Traditional | PDF ↗ |
| K211769 | OneLIF Intervertebral Body Replacement System | Novapproach Spine | 2021-09-07 | Traditional | PDF ↗ |
| K201671 | A-Link Z | Acuity Surgical Devices, LLC | 2021-05-04 | Traditional | PDF ↗ |
| K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021-04-09 | Traditional | PDF ↗ |
| K202032 | Idys LLIF 3DTi | Clariance, Sas | 2021-04-01 | Traditional | PDF ↗ |
| K210271 | NuVasive Modulus ALIF System | Nu Vasive, Incorporated | 2021-03-01 | Special | PDF ↗ |
| K203207 | Omnia Medical TiBrid-SA | Omnia Medical, LLC | 2020-12-23 | Traditional | PDF ↗ |
| K202230 | NEXXT MATRIXX Stand Alone ALIF System | Nexxt Spine, LLC | 2020-12-15 | Traditional | PDF ↗ |
| K202190 | Oculus-SA Lumbar Cage System | Neurostructures | 2020-10-02 | Traditional | PDF ↗ |
| K201585 | Monterey AL Interbody System | Stryker Corporation | 2020-08-10 | Traditional | PDF ↗ |
| K201087 | CORBEL Spacers | Globus Medical, Inc. | 2020-07-31 | Traditional | PDF ↗ |
| K200002 | Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device | 4Web, Inc. | 2020-05-29 | Traditional | PDF ↗ |
| K200352 | Axis Spine Technologies ALIF | Axis Spine Technologies, Ltd. | 2020-05-20 | Traditional | PDF ↗ |
| K200541 | Hive Stand-alone Anterior Lumbar Interbody System | Hd Lifesciences, LLC | 2020-04-28 | Traditional | PDF ↗ |
| K192492 | EL CAPITAN Anterior Lumber Interbody System | Astura Medical, LLC | 2020-04-21 | Traditional | PDF ↗ |
| K200338 | ProLift Lateral Fixated | Life Spine, Inc. | 2020-04-17 | Traditional | PDF ↗ |
| K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | 2020-03-25 | Traditional | PDF ↗ |
| K193320 | KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System | Kyocera Medical Technologies, Inc. | 2020-02-04 | Traditional | PDF ↗ |
| K192993 | SCARLET AL-T | Spineart | 2020-01-22 | Traditional | PDF ↗ |
| K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device | Titan Spine, Inc. | 2020-01-08 | Traditional | PDF ↗ |
| K191834 | Stand-Alone ALIF Titanium System | Life Spine, Inc. | 2019-12-16 | Traditional | PDF ↗ |
| K192168 | Idys ALIF ZP 3DTi | Clariance, Sas | 2019-11-04 | Traditional | PDF ↗ |
| K190179 | SAHARA Stabilization System | K2m, Inc. | 2019-10-03 | Traditional | PDF ↗ |
| K192054 | Endoskeleton TAS Plate | Titan Spine, Inc. | 2019-08-29 | Special | PDF ↗ |
| K192047 | Rampart One Lumbar Interbody Fusion System | Spineology, Inc. | 2019-08-23 | Special | PDF ↗ |
| K182139 | AXTi Titanium Stand-Alone ALIF System | Innovasis, Inc. | 2019-06-21 | Traditional | PDF ↗ |
| K191263 | Idys ALIF TiVac | Clariance, Sas | 2019-06-06 | Special | PDF ↗ |
| K190877 | Juliet® Ti LL Lumbar Interbody Device | Spineart | 2019-05-29 | Traditional | PDF ↗ |
| K191091 | Rampart One Lumbar Interbody Fusion System | Spineology, Inc. | 2019-05-23 | Special | PDF ↗ |
| K183426 | MectaLIF Anterior Stand Alone Extension | Medacta International S.A. | 2019-03-15 | Traditional | PDF ↗ |
| K181096 | Avenue P Cage System | Zimmer Biomet Spine, Inc. | 2019-01-15 | Traditional | PDF ↗ |
| K181118 | Reliance Lumbar IBF System | Reliance Medical Systems | 2019-01-09 | Traditional | PDF ↗ |
| K182007 | Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System | Renovis Surgical Technologies | 2018-12-07 | Traditional | PDF ↗ |
| K182195 | Arco-SA Lumbar Cage System | Neurostructures, Inc. | 2018-11-09 | Special | PDF ↗ |
| K181818 | Scarlet AL-T | Spineart | 2018-10-09 | Traditional | PDF ↗ |
| K180215 | DYNA-LINK ELITE Stand-Alone Anterior Lumbar System | Life Spine, Inc. | 2018-09-13 | Traditional | PDF ↗ |
| K181386 | NuVasive Brigade Lateral System | Nu Vasive, Incorporated | 2018-08-24 | Traditional | PDF ↗ |
| K180814 | CoreLink® M3 Stand-Alone Anterior Lumbar System | Corelink, LLC | 2018-08-10 | Traditional | PDF ↗ |
| K180695 | FBC 921 (ALIF) | Fbc Device Aps | 2018-07-12 | Traditional | PDF ↗ |
| K180502 | S128 Anterior Lumbar Interbody Fusion (ALIF) System | Renovis Surgical Technologies, Inc. | 2018-06-14 | Traditional | PDF ↗ |
| K180519 | HARRIER-SA Lumbar Interbody System | Choicespine, LP | 2018-05-16 | Traditional | PDF ↗ |
| K180002 | Rampart One Lumbar Interbody Fusion Device | Spineology, Inc. | 2018-04-25 | Traditional | PDF ↗ |
| K173432 | ENZA-A Titanium ALIF | Camber Spine Technologies | 2018-04-18 | Traditional | PDF ↗ |
Product code OVD · Class II · Orthopedic. Data: openFDA.