| SABER-XA System (K261408) | Elevation Spine | 2026-08-03 |
| Interwedge® Standalone Lateral (K261809) | Foundation Surgical Group | 2026-07-31 |
| Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System (K261353) | Kyocera Medical Technologies, Inc. | 2026-07-15 |
| Anteralign LS coverplate (K260810) | Tyber Medical, LLC | 2026-06-10 |
| MectaLIF 3D Metal Anterior (K254202) | Medacta International S.A. | 2026-05-05 |
| SCRIPT™ Implant System (K253401) | Globus Medical, Inc. | 2026-04-29 |
| Ventana™ A Anterior Lumbar Interbody System (K253559) | Spinal Elements, Inc. | 2026-02-25 |
| DeGen Medical Patient Specific Implant (PSI) System (K251829) | Degen Medical | 2025-12-08 |
| IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System (K251575) | Alphatec Spine | 2025-09-03 |
| CONDUIT™ SYNFIX™ Evolution Secured Spacer System (K250072) | Avalign Technologies, Inc. | 2025-07-10 |
| ProAM ALIF System (K251644) | Pro Surgical, Inc. | 2025-06-24 |
| Curiteva Porous PEEK Standalone ALIF System (K250845) | Curiteva, Inc. | 2025-06-18 |
| OneLIF™ Interbody Fusion System (K251459) | Novapproach Spine, LLC | 2025-06-12 |
| Stable-L Lumbar Interbody System (K243934) | Nexus Spine, LLC | 2025-04-30 |
| Ventris Intervertebral Body Fusion Device (K243386) | Acuity Surgical Devices, LLC | 2025-04-22 |
| AxTiHA® Stand-Alone ALIF System (K250603) | Innovasis | 2025-03-24 |
| aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation (K243802) | Carlsmed, Inc. | 2025-03-17 |
| aprevo® anterior lumbar interbody fusion device with interfixation (K243635) | Carlsmed, Inc. | 2024-12-13 |
| Atlas Spine Lateral Expandable Interbody System (K243191) | Atlas Spine, Inc. | 2024-11-26 |
| DeGen Medical Patient Specific Implant (PSI) System (K241077) | Degen Medical | 2024-10-29 |
| Catalyft™ LS Expandable Interbody System (K241992) | Medtronic Sofamor Danek USA, Inc. | 2024-10-28 |
| aprevo® anterior lumbar interbody fusion device with interfixation (K241477) | Carlsmed, Inc. | 2024-10-09 |
| Interwedge® Standalone Lateral (K241487) | Foundation Surgical Group, Inc. | 2024-10-02 |
| Juliet® Ti LL Lumbar Interbody Device (K241321) | Spineart SA | 2024-07-18 |
| E3D™-A Interbody System (K240368) | Evolution Spine | 2024-05-15 |
| ProAM ALIF System (K240126) | Pro Surgical, Inc. | 2024-05-03 |
| Omnia Medical TiBrid™-SA System (K240623) | Omnia Medical, LLC | 2024-04-24 |
| Anterior Spine Truss System-Stand Alone (ASTS-SA) (K233966) | 4Web Medical, Inc. | 2024-04-22 |
| E3D™-A Interbody System (K232432) | Evolution Spine | 2024-01-30 |
| MectaLIF Anterior Lag Extension (K232123) | Medacta International S.A. | 2023-10-18 |
| Stable-L Standalone Lumbar Interbody System (K231486) | Nexus Spine, LLC | 2023-10-12 |
| IdentiTi ALIF Interbody Systems (K232097) | Alphatec Spine, Inc. | 2023-09-25 |
| Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System (K232530) | Nexus Spine, LLC | 2023-09-18 |
| MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation (K232154) | MiRus, LLC | 2023-09-11 |
| NuVasive Modulus ALIF System (K230894) | Nu Vasive, Incorporated | 2023-06-16 |
| Zavation ALIF System (K230731) | Zavation Medical Products, LLC | 2023-06-14 |
| PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System (K230808) | Kyocera Medical Technologies, Inc. | 2023-04-21 |
| ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) (K221324) | Camber Spine Technologies | 2023-03-30 |
| Pisces™-SA STANDALONE ALIF Interbody System (K223413) | Osseus Fusion Systems | 2023-02-10 |
| EVOLUTION SPINE Interbody System (K223146) | Evolution Spine | 2023-02-07 |
| EL CAPITAN Anterior Lumbar Interbody Fusion (K222554) | Astura Medical | 2023-01-19 |
| aprevo® anterior lumbar interbody fusion device with interfixation (K222009) | Carlsmed, Inc. | 2022-11-22 |
| MectaLIF Anterior Extension (K221545) | Medacta International S.A. | 2022-10-24 |
| NuVasive Cohere ALIF System Intervertebral Body Fusion Device (K221751) | Nu Vasive, Incorporated | 2022-10-21 |
| Standalone ALIF Interbody Fusion System (K221936) | Eminent Spine | 2022-10-17 |
| Southern Anterior Screw Fixated Cage (SASCA) (K221447) | Southern Medical (Pty) , Ltd. | 2022-10-14 |
| Align (K222561) | Acuity Surgical Devices, LLC | 2022-09-23 |
| SOLO-L (K220610) | Aurora Spine, Inc. | 2022-05-27 |
| ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System (K220115) | MiRus, LLC | 2022-05-13 |
| PISCES-SA Standalone ALIF Interbody System (K213935) | Osseus Fusion Systems | 2022-05-06 |
| Altus Spine Interbody Standalone Fusion System (K211837) | Altus Partners, LLC | 2022-04-19 |
| Dakota ALIF System (K213118) | Precision Spine, Inc. | 2022-04-01 |
| EL CAPITAN Anterior Lumbar Interbody Fusion System (K214047) | Astura Medical | 2022-03-30 |
| Stable-L Standalone Lumbar Interbody System (K212498) | Nexus Spine, LLC | 2022-03-18 |
| Tesera-k ALIF System (K212980) | Kyocera Medical Technologies, Inc. | 2022-01-07 |
| AxTiHA Stand-Alone ALIF System (K212967) | Innovasis, Inc. | 2021-10-15 |
| Axis Spine Technologies ALIF (K210590) | Axis Spine Technologies, Ltd. | 2021-09-29 |
| OneLIF Intervertebral Body Replacement System (K211769) | Novapproach Spine | 2021-09-07 |
| A-Link Z (K201671) | Acuity Surgical Devices, LLC | 2021-05-04 |
| IdentiTi ALIF Standalone Interbody System (K203742) | Alphatec Spine, Inc. | 2021-04-09 |
| Idys LLIF 3DTi (K202032) | Clariance, Sas | 2021-04-01 |
| NuVasive Modulus ALIF System (K210271) | Nu Vasive, Incorporated | 2021-03-01 |
| Omnia Medical TiBrid-SA (K203207) | Omnia Medical, LLC | 2020-12-23 |
| NEXXT MATRIXX Stand Alone ALIF System (K202230) | Nexxt Spine, LLC | 2020-12-15 |
| Oculus-SA Lumbar Cage System (K202190) | Neurostructures | 2020-10-02 |
| Monterey AL Interbody System (K201585) | Stryker Corporation | 2020-08-10 |
| CORBEL Spacers (K201087) | Globus Medical, Inc. | 2020-07-31 |
| Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device (K200002) | 4Web, Inc. | 2020-05-29 |
| Axis Spine Technologies ALIF (K200352) | Axis Spine Technologies, Ltd. | 2020-05-20 |
| Hive™ Stand-alone Anterior Lumbar Interbody System (K200541) | Hd Lifesciences, LLC | 2020-04-28 |
| EL CAPITAN Anterior Lumber Interbody System (K192492) | Astura Medical, LLC | 2020-04-21 |
| ProLift Lateral Fixated (K200338) | Life Spine, Inc. | 2020-04-17 |
| NuVasive 3DP Interfixated ALIF System (K193593) | Nu Vasive, Incorporated | 2020-03-25 |
| KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System (K193320) | Kyocera Medical Technologies, Inc. | 2020-02-04 |
| SCARLET AL-T (K192993) | Spineart | 2020-01-22 |
| Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device (K191581) | Titan Spine, Inc. | 2020-01-08 |
| Stand-Alone ALIF Titanium System (K191834) | Life Spine, Inc. | 2019-12-16 |
| Idys ALIF ZP 3DTi (K192168) | Clariance, Sas | 2019-11-04 |
| SAHARA Stabilization System (K190179) | K2m, Inc. | 2019-10-03 |
| Endoskeleton TAS Plate (K192054) | Titan Spine, Inc. | 2019-08-29 |
| Rampart™ One Lumbar Interbody Fusion System (K192047) | Spineology, Inc. | 2019-08-23 |
| AXTi Titanium Stand-Alone ALIF System (K182139) | Innovasis, Inc. | 2019-06-21 |
| Idys ALIF TiVac (K191263) | Clariance, Sas | 2019-06-06 |
| Juliet® Ti LL Lumbar Interbody Device (K190877) | Spineart | 2019-05-29 |
| Rampart One Lumbar Interbody Fusion System (K191091) | Spineology, Inc. | 2019-05-23 |
| MectaLIF Anterior Stand Alone Extension (K183426) | Medacta International S.A. | 2019-03-15 |
| Avenue P Cage System (K181096) | Zimmer Biomet Spine, Inc. | 2019-01-15 |
| Reliance Lumbar IBF System (K181118) | Reliance Medical Systems | 2019-01-09 |
| Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System (K182007) | Renovis Surgical Technologies | 2018-12-07 |
| Arco™-SA Lumbar Cage System (K182195) | Neurostructures, Inc. | 2018-11-09 |
| Scarlet AL-T (K181818) | Spineart | 2018-10-09 |
| DYNA-LINK ELITE Stand-Alone Anterior Lumbar System (K180215) | Life Spine, Inc. | 2018-09-13 |
| NuVasive Brigade Lateral System (K181386) | Nu Vasive, Incorporated | 2018-08-24 |
| CoreLink® M3™ Stand-Alone Anterior Lumbar System (K180814) | Corelink, LLC | 2018-08-10 |
| FBC 921 (ALIF) (K180695) | Fbc Device Aps | 2018-07-12 |
| S128 Anterior Lumbar Interbody Fusion (ALIF) System (K180502) | Renovis Surgical Technologies, Inc. | 2018-06-14 |
| HARRIER-SA™ Lumbar Interbody System (K180519) | Choicespine, LP | 2018-05-16 |
| Rampart One Lumbar Interbody Fusion Device (K180002) | Spineology, Inc. | 2018-04-25 |
| ENZA-A Titanium ALIF (K173432) | Camber Spine Technologies | 2018-04-18 |
| SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device (K173606) | SeaSpine Orthopedics Corporation | 2018-04-13 |