OVD · Intervertebral Fusion Device With Integrated Fixation, Lumbar
Orthopedic · 21 CFR 888.3080 · Class 2
Overview
| Product Code | OVD |
|---|---|
| Device Name | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Regulation | 21 CFR 888.3080 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
| Implant | Yes |
Identification
An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.
Classification Rationale
(1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
Special Controls
*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
Cleared Devices (198)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253559 | Ventana A Anterior Lumbar Interbody System | Spinal Elements, Inc. | Feb 25, 2026 | SESE |
| K251829 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | Dec 8, 2025 | SESE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody System | Alphatec Spine | Sep 3, 2025 | SESE |
| K250072 | CONDUIT SYNFIX Evolution Secured Spacer System | Avalign Technologies, Inc. | Jul 10, 2025 | SESE |
| K251644 | ProAM ALIF System | Pro Surgical, Inc. | Jun 24, 2025 | SESE |
| K250845 | Curiteva Porous PEEK Standalone ALIF System | Curiteva, Inc. | Jun 18, 2025 | SESE |
| K251459 | OneLIF Interbody Fusion System | Novapproach Spine, LLC | Jun 12, 2025 | SESE |
| K243934 | Stable-L Lumbar Interbody System | Nexus Spine, LLC | Apr 30, 2025 | SESE |
| K243386 | Ventris Intervertebral Body Fusion Device | Acuity Surgical Devices, LLC | Apr 22, 2025 | SESE |
| K250603 | AxTiHA® Stand-Alone ALIF System | Innovasis | Mar 24, 2025 | SESE |
| K243802 | aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | Mar 17, 2025 | SESE |
| K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | Dec 13, 2024 | SESE |
| K243191 | Atlas Spine Lateral Expandable Interbody System | Atlas Spine, Inc. | Nov 26, 2024 | SESE |
| K241077 | DeGen Medical Patient Specific Implant (PSI) System | Degen Medical | Oct 29, 2024 | SESE |
| K241992 | Catalyft LS Expandable Interbody System | Medtronic Sofamor Danek USA, Inc. | Oct 28, 2024 | SESE |
| K241477 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | Oct 9, 2024 | SESE |
| K241487 | Interwedge® Standalone Lateral | Foundation Surgical Group, Inc. | Oct 2, 2024 | SESE |
| K241321 | Juliet® Ti LL Lumbar Interbody Device | Spineart SA | Jul 18, 2024 | SESE |
| K240368 | E3D-A Interbody System | Evolution Spine | May 15, 2024 | SESE |
| K240126 | ProAM ALIF System | Pro Surgical, Inc. | May 3, 2024 | SESE |
| K240623 | Omnia Medical TiBrid-SA System | Omnia Medical, LLC | Apr 24, 2024 | SESE |
| K233966 | Anterior Spine Truss System-Stand Alone (ASTS-SA) | 4Web Medical, Inc. | Apr 22, 2024 | SESE |
| K232432 | E3D-A Interbody System | Evolution Spine | Jan 30, 2024 | SESE |
| K232123 | MectaLIF Anterior Lag Extension | Medacta International S.A. | Oct 18, 2023 | SESE |
| K231486 | Stable-L Standalone Lumbar Interbody System | Nexus Spine, LLC | Oct 12, 2023 | SESE |
| K232097 | IdentiTi ALIF Interbody Systems | Alphatec Spine, Inc. | Sep 25, 2023 | SESE |
| K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System | Nexus Spine, LLC | Sep 18, 2023 | SESE |
| K232154 | MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation | MiRus, LLC | Sep 11, 2023 | SESE |
| K230894 | NuVasive Modulus ALIF System | Nu Vasive, Incorporated | Jun 16, 2023 | SESE |
| K230731 | Zavation ALIF System | Zavation Medical Products, LLC | Jun 14, 2023 | SESE |
| K230808 | PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System | Kyocera Medical Technologies, Inc. | Apr 21, 2023 | SESE |
| K221324 | ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) | Camber Spine Technologies | Mar 30, 2023 | SESE |
| K223413 | Pisces-SA STANDALONE ALIF Interbody System | Osseus Fusion Systems | Feb 10, 2023 | SESE |
| K223146 | EVOLUTION SPINE Interbody System | Evolution Spine | Feb 7, 2023 | SESE |
| K222554 | EL CAPITAN Anterior Lumbar Interbody Fusion | Astura Medical | Jan 19, 2023 | SESE |
| K222009 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | Nov 22, 2022 | SESE |
| K221545 | MectaLIF Anterior Extension | Medacta International S.A. | Oct 24, 2022 | SESE |
| K221751 | NuVasive Cohere ALIF System Intervertebral Body Fusion Device | Nu Vasive, Incorporated | Oct 21, 2022 | SESE |
| K221936 | Standalone ALIF Interbody Fusion System | Eminent Spine | Oct 17, 2022 | SESE |
| K221447 | Southern Anterior Screw Fixated Cage (SASCA) | Southern Medical (Pty) , Ltd. | Oct 14, 2022 | SESE |
| K222561 | Align | Acuity Surgical Devices, LLC | Sep 23, 2022 | SESE |
| K220610 | SOLO-L | Aurora Spine, Inc. | May 27, 2022 | SESE |
| K220115 | ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System | MiRus, LLC | May 13, 2022 | SESE |
| K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | May 6, 2022 | SESE |
| K211837 | Altus Spine Interbody Standalone Fusion System | Altus Partners, LLC | Apr 19, 2022 | SESE |
| K213118 | Dakota ALIF System | Precision Spine, Inc. | Apr 1, 2022 | SESE |
| K214047 | EL CAPITAN Anterior Lumbar Interbody Fusion System | Astura Medical | Mar 30, 2022 | SESE |
| K212498 | Stable-L Standalone Lumbar Interbody System | Nexus Spine, LLC | Mar 18, 2022 | SESE |
| K212980 | Tesera-k ALIF System | Kyocera Medical Technologies, Inc. | Jan 7, 2022 | SESE |
| K212967 | AxTiHA Stand-Alone ALIF System | Innovasis, Inc. | Oct 15, 2021 | SESE |
| K210590 | Axis Spine Technologies ALIF | Axis Spine Technologies, Ltd. | Sep 29, 2021 | SESE |
| K211769 | OneLIF Intervertebral Body Replacement System | Novapproach Spine | Sep 7, 2021 | SESE |
| K201671 | A-Link Z | Acuity Surgical Devices, LLC | May 4, 2021 | SESE |
| K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | Apr 9, 2021 | SESE |
| K202032 | Idys LLIF 3DTi | Clariance, Sas | Apr 1, 2021 | SESE |
| K210271 | NuVasive Modulus ALIF System | Nu Vasive, Incorporated | Mar 1, 2021 | SESE |
| K203207 | Omnia Medical TiBrid-SA | Omnia Medical, LLC | Dec 23, 2020 | SESE |
| K202230 | NEXXT MATRIXX Stand Alone ALIF System | Nexxt Spine, LLC | Dec 15, 2020 | SESE |
| K202190 | Oculus-SA Lumbar Cage System | Neurostructures | Oct 2, 2020 | SESE |
| K201585 | Monterey AL Interbody System | Stryker Corporation | Aug 10, 2020 | SESE |
| K201087 | CORBEL Spacers | Globus Medical, Inc. | Jul 31, 2020 | SESE |
| K200002 | Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion Device | 4Web, Inc. | May 29, 2020 | SESE |
| K200352 | Axis Spine Technologies ALIF | Axis Spine Technologies, Ltd. | May 20, 2020 | SESE |
| K200541 | Hive Stand-alone Anterior Lumbar Interbody System | Hd Lifesciences, LLC | Apr 28, 2020 | SESE |
| K192492 | EL CAPITAN Anterior Lumber Interbody System | Astura Medical, LLC | Apr 21, 2020 | SESE |
| K200338 | ProLift Lateral Fixated | Life Spine, Inc. | Apr 17, 2020 | SESE |
| K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | Mar 25, 2020 | SESE |
| K193320 | KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System | Kyocera Medical Technologies, Inc. | Feb 4, 2020 | SESE |
| K192993 | SCARLET AL-T | Spineart | Jan 22, 2020 | SESE |
| K191581 | Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device | Titan Spine, Inc. | Jan 8, 2020 | SESE |
| K191834 | Stand-Alone ALIF Titanium System | Life Spine, Inc. | Dec 16, 2019 | SESE |
| K192168 | Idys ALIF ZP 3DTi | Clariance, Sas | Nov 4, 2019 | SESE |
| K190179 | SAHARA Stabilization System | K2m, Inc. | Oct 3, 2019 | SESE |
| K192054 | Endoskeleton TAS Plate | Titan Spine, Inc. | Aug 29, 2019 | SESE |
| K192047 | Rampart One Lumbar Interbody Fusion System | Spineology, Inc. | Aug 23, 2019 | SESE |
| K182139 | AXTi Titanium Stand-Alone ALIF System | Innovasis, Inc. | Jun 21, 2019 | SESE |
| K191263 | Idys ALIF TiVac | Clariance, Sas | Jun 6, 2019 | SESE |
| K190877 | Juliet® Ti LL Lumbar Interbody Device | Spineart | May 29, 2019 | SESE |
| K191091 | Rampart One Lumbar Interbody Fusion System | Spineology, Inc. | May 23, 2019 | SESE |
| K183426 | MectaLIF Anterior Stand Alone Extension | Medacta International S.A. | Mar 15, 2019 | SESE |
| K181096 | Avenue P Cage System | Zimmer Biomet Spine, Inc. | Jan 15, 2019 | SESE |
| K181118 | Reliance Lumbar IBF System | Reliance Medical Systems | Jan 9, 2019 | SESE |
| K182007 | Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System | Renovis Surgical Technologies | Dec 7, 2018 | SESE |
| K182195 | Arco-SA Lumbar Cage System | Neurostructures, Inc. | Nov 9, 2018 | SESE |
| K181818 | Scarlet AL-T | Spineart | Oct 9, 2018 | SESE |
| K180215 | DYNA-LINK ELITE Stand-Alone Anterior Lumbar System | Life Spine, Inc. | Sep 13, 2018 | SESE |
| K181386 | NuVasive Brigade Lateral System | Nu Vasive, Incorporated | Aug 24, 2018 | SESE |
| K180814 | CoreLink® M3 Stand-Alone Anterior Lumbar System | Corelink, LLC | Aug 10, 2018 | SESE |
| K180695 | FBC 921 (ALIF) | Fbc Device Aps | Jul 12, 2018 | SESE |
| K180502 | S128 Anterior Lumbar Interbody Fusion (ALIF) System | Renovis Surgical Technologies, Inc. | Jun 14, 2018 | SESE |
| K180519 | HARRIER-SA Lumbar Interbody System | Choicespine, LP | May 16, 2018 | SESE |
| K180002 | Rampart One Lumbar Interbody Fusion Device | Spineology, Inc. | Apr 25, 2018 | SESE |
| K173432 | ENZA-A Titanium ALIF | Camber Spine Technologies | Apr 18, 2018 | SESE |
| K173606 | SeaSpine Vu aPOD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu aPOD Prime Intervertebral Body Fusion Device | SeaSpine Orthopedics Corporation | Apr 13, 2018 | SESE |
| K173082 | Arco-SA Lumbar Cage System | Neurostructures, Inc. | Mar 29, 2018 | SESE |
| K172941 | CASCADIA Interbody System | K2m | Feb 12, 2018 | SESE |
| K172019 | Brisbane ALIF Device, Gladstone ALIF Device | Signature Orthopaedics Pty, Ltd. | Nov 29, 2017 | SESE |
| K172083 | Idys ALIF System | Clariance, Sas | Nov 8, 2017 | SESE |
| K172328 | SOVEREIGN Spinal System | Medtronic Sofamor Danek USA, Inc. | Nov 2, 2017 | SESE |
| K170157 | INDEPENDENCE® Spacers | Globus Medical, Inc. | Sep 25, 2017 | SESE |
| K170855 | T-Rex Standalone ALIF | Siats, LLC | Sep 7, 2017 | SESE |
| K171567 | IRIX-A Lumbar Integrated Fusion System | X-Spine Systems, Inc. | Aug 28, 2017 | SESE |
| K163670 | Rampart One Lumbar Interbody Fusion Device | Spineology, Inc. | May 8, 2017 | SESE |
| K170592 | NuVasive BASE Interfixated Titanium System | Nu Vasive, Incorporated | Apr 26, 2017 | SESE |
| K162236 | Ax Stand-Alone ALIF System | Innovasis, Inc. | Apr 20, 2017 | SESE |
| K163269 | Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device | Titan Spine, LLC | Apr 13, 2017 | SESE |
| K170455 | MectaLIF Anterior Stand Alone | Medacta International S.A. | Mar 16, 2017 | SESE |
| K163543 | Biomet Fusion System | Zimmer Biomet Spine, Inc. | Feb 28, 2017 | SESE |
| K162680 | SOVEREIGN® Spinal System | Medtronic Sofamor Danek USA, Inc. | Dec 14, 2016 | SESE |
| K162351 | SeaSpine® Vu aPOD Prime NanoMetalene® Intervertebral Body Fusion Device | SeaSpine Orthopedics Corporation | Dec 1, 2016 | SESE |
| K161993 | Leva® Anterior Interbody System | Spine Wave, Inc. | Nov 22, 2016 | SESE |
| K161379 | ELSA Spacers | Globus Medical, Inc. | Sep 29, 2016 | SESE |
| K161173 | Avenue® T TLIF Cage | Ldr Spine USA, Inc. | Sep 28, 2016 | SESE |
| K161129 | PILLAR SA PTC | Orthofix, Inc. | Sep 8, 2016 | SESE |
| K160597 | INDEPENDENCE MIS Spacers | Globus Medical, Inc. | Aug 29, 2016 | SESE |
| K160605 | MectaLIF Anterior Stand-Alone | Medacta International | Jul 21, 2016 | SESE |
| K161223 | TransContinental® M Spacers and InterContinental® Plate-Spacers | Globus Medical, Inc. | Jul 15, 2016 | SESE |
| K153720 | ENZA Zero-Profile Anterior Interbody Fusion | Camber Spine Technologies | May 3, 2016 | SESE |
| K160051 | NuVasive® Interfixated Interbody System | Nu Vasive, Incorporated | Apr 20, 2016 | SESE |
| K160291 | Optimus ALIF System | Amendia, Inc. | Feb 18, 2016 | SESE |
| K151312 | VerteLP Interbody Fusion Device | Vgi, LLC | Jan 13, 2016 | SESE |
| K151481 | Sahara Stabilization System | K2m, Inc. | Dec 21, 2015 | SESE |
| K152943 | NuVasive Foundation-LL System | Nu Vasive, Incorporated | Dec 1, 2015 | SESE |
| K150673 | SYNFIX Evolution Secured Spacer System | Synthes (USA) Products, LLC | Aug 21, 2015 | SESE |
| K151214 | ALIF Interfixated System | Nu Vasive, Incorporated | Jun 25, 2015 | SESE |
| K142645 | Avenue T TLIF Cage | Ldr Spine USA, Inc. | Jun 11, 2015 | SESE |
| K150643 | Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti | Centinel Spine, Inc. | Jun 8, 2015 | SESE |
| K142487 | Chesapeake Stabilization System | K2m, Inc. | May 7, 2015 | SESE |
| K143228 | Ancora LLC Interbody Fusion Device | Frontier Medical Devices, Inc. | Feb 26, 2015 | SESE |
| K142498 | MAGNIFY and MAGNIFY-S Spacers | Globus Medical, Inc. | Feb 26, 2015 | SESE |
| K141798 | SYPHER SPACER SYSTEM | Biogennix, LLC | Feb 19, 2015 | SESE |
| K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL and PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System | Stryker Corporation | Jan 26, 2015 | SESE |
| K141187 | IMPIX ALIF S/A | Medicrea International SA | Jan 15, 2015 | SESE |
| K142271 | Zavation Z-Link Lumbar | Zavation, LLC | Dec 19, 2014 | SESE |
| K133827 | A-LINK Z | Osteo Vasive, LLC | Nov 17, 2014 | SESE |
| K142066 | AERO-LL LUMBAR CAGE SYSTEM | Stryker Corporation | Nov 13, 2014 | SESE |
| K141942 | MIDLINE II TI | Centinel Spine, Inc. | Nov 7, 2014 | SESE |
| K142095 | RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM | Renovis Surgical Technologies, Inc. | Oct 15, 2014 | SESE |
| K141791 | BIOMET FUSION SYSTEM | Biomet Spine | Oct 9, 2014 | SESE |
| K133947 | IRIX-A LUMBAR INTEGRATED FUSION SYSTEM | X-Spine Systems, Inc. | Jul 29, 2014 | SESE |
| K140479 | COROENT XL-F SYSTEM | Nu Vasive, Incorporated | Jul 28, 2014 | SESE |
| K133494 | CHESAPEAKE SPINAL SYSTEM | K2m, Inc. | Jun 10, 2014 | SESE |
| K133328 | AERO-AL LUMBAR CAGE SYSTEM | Stryker Corporation | May 30, 2014 | SESE |
| K132596 | PROPOSED OPTIMUS | Custom Spine, Inc. | Apr 11, 2014 | SESE |
| K140106 | S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM | Renovis Surgical Technologies, Inc. | Mar 27, 2014 | SESE |
| K133286 | MIDLINE (TM) | Centinel Spine, Inc. | Jan 9, 2014 | SESE |
| K131276 | LATERAL SYNFIX | Synthes (USA) Products, LLC | Jan 6, 2014 | SESE |
| K132559 | MONUMENT SPACERS | Globus Medical, Inc. | Dec 30, 2013 | SESE |
| K131723 | COROENT SINGLE TAB SYSTEM | Nuvasive, Inc. | Sep 20, 2013 | SESE |
| K131122 | S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM | Renovis Surgical Technologies, LLC | Sep 18, 2013 | SESE |
| K130641 | LOGIC STAND-ALONE INTERVERTEBRAL BODY FUSION DEVICE | Binder Biomedical, Inc. | Sep 13, 2013 | SESE |
| K130461 | STALIF X | Centinel Spine, Inc. | Aug 28, 2013 | SESE |
| K131547 | LANX FUSION SYSTEM | Lanx, Inc. | Jul 12, 2013 | SESE |
| K124034 | MECTALIF ANTERIOR | Medacta International | May 17, 2013 | SESE |
| K130445 | VAULT ALIF SYSTEM | Spinal USA | Apr 25, 2013 | SESE |
| K123045 | BRIGADE STANDALONE SYSTEM | Nuvasive, Inc. | Apr 16, 2013 | SESE |
| K123767 | LANX FUSION SYSTEM- SA | Lanx, Inc. | Mar 18, 2013 | SESE |
| K123993 | SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM | Alphatec Spine, Inc. | Mar 5, 2013 | SESE |
| K112700 | FRONTIER SADL INTERBODY FUSION DEVICE | Frontier Medical Devices, Inc. | Nov 1, 2012 | SESE |
| K120869 | ANCHOR-L LUMBAR CAGE | Stryker Spine | Oct 25, 2012 | SESE |
| K122168 | VISUALIF CHALLENGING ACCESS PLATE | Spine Smith Partners L.P. | Oct 11, 2012 | SESE |
| K121982 | SOVEREIGN SPINAL SYSTEM | Medtronic Sofamor Danek | Jul 26, 2012 | SESE |
| K113285 | LDR SPINE USA AVENUE L INTERBODY FUSION | Ldr Spine USA, Inc. | Jul 26, 2012 | SESE |
| K121211 | VU APOD INTERVERTEBRAL BODY FUSION DEVICE | Theken Spine, LLC | Jun 27, 2012 | SESE |
| K120101 | INDEPENDENCE SPACER | Globus Medical, Inc. | Mar 27, 2012 | SESE |
| K120557 | SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 | Biomet Spine & Bone Healing Technologies | Mar 19, 2012 | SESE |
| K120031 | CHESAPEAKE SPINAL SYSTEM | K2m, Inc. | Mar 16, 2012 | SESE |
| K112561 | NUVASIVE COROENT NO-PROFILE SYSTEM | Nuvasive, Inc. | Mar 13, 2012 | SESE |
| K110063 | SOVEREIGN SPINAL SYSTEM | Medtronic Sofamor Danek, Inc. | Oct 4, 2011 | SESE |
| K110327 | LDR SPINE ROI-A INTERBODY FUSION SYSTEM | Ldr Spine USA | Sep 30, 2011 | SESE |
| K111626 | ENDOSKELETON(R) TAS | Titan Spine, LLC | Sep 9, 2011 | SESE |
| K111122 | AESCULAP SIBD XP SPINAL SYSTEM | Aesculap Implant Systems, Inc. | Aug 4, 2011 | SESE |
| K103382 | INTERCONTINENTAL PLATE-SPACER | Globus Medical, Inc. | May 20, 2011 | SESE |
| K103369 | VAULT ALIF SYSTEM | Spinal USA | Apr 4, 2011 | SESE |
| K102402 | SOLUS ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SPINAL SPACER SYSTEM | Alphatec Spine, Inc. | Mar 30, 2011 | SESE |
| K102738 | LANX FUSION SYSTEM | Lanx, LLC | Feb 10, 2011 | SESE |
| K102121 | ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR | Apollo Spine, Inc. | Jan 12, 2011 | SESE |
| K100516 | ANYPLUS PEEK CAGES | GS Medical Co., Ltd. | Dec 3, 2010 | SESE |
| K102090 | SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM | Spine Smith Partners L.P. | Sep 30, 2010 | SESE |
| K101310 | VU APOD INTERVERTEBRAL BODY FUSION DEVICE | Theken Spine, LLC | Sep 2, 2010 | SESE |
| K100802 | AESCULAP IMPLANT SYSTEMS SIBD SPINAL SYSTEM | Aesculap Implant Systems, Inc. | Jul 20, 2010 | SESE |
| K100043 | COROENT XLR STANDALONE SYSTEM | Nuvasive, Inc. | Jun 16, 2010 | SESE |
| K093808 | INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE | Incite Innovation, LLC | Mar 24, 2010 | SESE |
| K093629 | SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM | Biomet Spine | Mar 9, 2010 | SESE |
| K092211 | CHESAPEAKE SPINAL SYSTEM | K2m, Inc. | Mar 5, 2010 | SESE |
| K091301 | LIFE SPINE STAND-ALONE SPACER SYSTEM | Life Spine | Dec 15, 2009 | SESE |
| K091813 | INTREPID SPINAL SYSTEM | Medtronic Sofamor Danek | Nov 17, 2009 | SESE |
| K083475 | LUCENT MAGNUM | Spinal Elements, Inc. | Feb 13, 2009 | SESE |
| K082926 | ZUMA, MODEL 55-XXXX/56-XXXX | Seaspine, Inc. | Dec 22, 2008 | SESE |
| K082252 | INDEPENDENCE SPACER | Globus Medical, Inc. | Nov 5, 2008 | SESE |
| K081711 | LUCENT MAGNUM+ | Spinal Elements, Inc. | Sep 11, 2008 | SESE |
| K081849 | BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE | Blackstone Medical, Inc. | Aug 28, 2008 | SESE |
| K081501 | SOLITAIRE ANTERIOR SPINAL SYSTEM | Biomet Spine | Jul 2, 2008 | SESE |
| K080822 | VU APOD INTERVERTABRAL BODY FUSION DEVICE | Theken Spine, LLC | Jul 2, 2008 | SESE |
| K081395 | SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM | Biomet Spine | Jun 25, 2008 | SESE |
| K073109 | STALIF TT INTERVERTEBRAL BODY FUSION SYSTEM | Surgicraft , Ltd. | Jun 4, 2008 | SESE |
| K072253 | SYNFIX-LR SPACER | Synthes Spine Co.Lp | Oct 12, 2007 | SESE |
| K071922 | INTERPLATE INTERBODY FUSION DEVICE, MODELS C, CGC, L AND LGC | Rsb Spine, LLC | Sep 18, 2007 | SESE |
Top Applicants
- Nu Vasive, Incorporated — 10 clearances
- Globus Medical, Inc. — 10 clearances
- K2m, Inc. — 6 clearances
- Stryker Corporation — 4 clearances
- Spineology, Inc. — 4 clearances
