ClearanceBrief
Panels › Orthopedic › Product code OVD · Class 2

Intervertebral Fusion Device With Integrated Fixation, Lumbar

Regulation 888.3080

9510(k)s in 12 months (205 all time)
2recalls in 12 months (36 all time)
36recalls that name a 510(k)
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Top companies in OVD

Company510(k)sRecalls
Medtronic Sofamor Danek68
Globus Medical, Inc.110
Nu Vasive, Incorporated100
Biomet Spine44
K2m70
Medacta International70
Alphatec Spine51
Medacta Usa Inc06
Acuity Surgical Devices, LLC32
Renovis Surgical Technologies50
Decided510(k)Device and applicantCode
Sep 11, 2026K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF Sy
INNO Holdings Inc. DBA Innovasis
OVD
Aug 3, 2026K261408SABER-XA System
Elevation Spine
OVD
Jul 31, 2026K261809Interwedge® Standalone Lateral
Foundation Surgical Group
OVD
Jul 15, 2026K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor System
Kyocera Medical Technologies, Inc.
OVD
Jun 10, 2026K260810Anteralign LS coverplate
Tyber Medical, LLC
OVD
May 5, 2026K254202MectaLIF 3D Metal Anterior
Medacta International S.A., CH
OVD
Apr 29, 2026K253401SCRIPT™ Implant System
Globus Medical, Inc.
OVD
Feb 25, 2026K253559Ventana™ A Anterior Lumbar Interbody System
Spinal Elements, Inc.
OVD
Dec 8, 2025K251829DeGen Medical Patient Specific Implant (PSI) System
Degen Medical
OVD
Sep 3, 2025K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System
Alphatec Spine
OVD
Jul 10, 2025K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer System
Avalign Technologies, Inc.
OVD
Jun 24, 2025K251644ProAM ALIF System
Pro Surgical, Inc.
OVD
Jun 18, 2025K250845Curiteva Porous PEEK Standalone ALIF System
Curiteva, Inc.
OVD
Jun 12, 2025K251459OneLIF™ Interbody Fusion System
Novapproach Spine, LLC
OVD
Apr 30, 2025K243934Stable-L Lumbar Interbody System
Nexus Spine, LLC
OVD
Apr 22, 2025K243386Ventris Intervertebral Body Fusion Device
Acuity Surgical Devices, LLC
OVD
Mar 24, 2025K250603AxTiHA® Stand-Alone ALIF System
Innovasis
OVD
Mar 17, 2025K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interf
Carlsmed, Inc.
OVD
Dec 13, 2024K243635aprevo® anterior lumbar interbody fusion device with interfixation
Carlsmed, Inc.
OVD
Nov 26, 2024K243191Atlas Spine Lateral Expandable Interbody System
Atlas Spine, Inc.
OVD
Oct 29, 2024K241077DeGen Medical Patient Specific Implant (PSI) System
Degen Medical
OVD
Oct 28, 2024K241992Catalyft™ LS Expandable Interbody System
Medtronic Sofamor Danek USA, Inc.
OVD
Oct 9, 2024K241477aprevo® anterior lumbar interbody fusion device with interfixation
Carlsmed, Inc.
OVD
Oct 2, 2024K241487Interwedge® Standalone Lateral
Foundation Surgical Group, Inc.
OVD
Jul 18, 2024K241321Juliet® Ti LL Lumbar Interbody Device
Spineart SA, CH
OVD
May 15, 2024K240368E3D™-A Interbody System
Evolution Spine
OVD
May 3, 2024K240126ProAM ALIF System
Pro Surgical, Inc.
OVD
Apr 24, 2024K240623Omnia Medical TiBrid™-SA System
Omnia Medical, LLC
OVD
Apr 22, 2024K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)
4Web Medical, Inc.
OVD
Jan 30, 2024K232432E3D™-A Interbody System
Evolution Spine
OVD
Oct 18, 2023K232123MectaLIF Anterior Lag Extension
Medacta International S.A., CH
OVD
Oct 12, 2023K231486Stable-L Standalone Lumbar Interbody System
Nexus Spine, LLC
OVD
Sep 25, 2023K232097IdentiTi ALIF Interbody Systems
Alphatec Spine, Inc.
OVD
Sep 18, 2023K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System
Nexus Spine, LLC
OVD
Sep 11, 2023K232154MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation
MiRus, LLC
OVD
Jun 16, 2023K230894NuVasive Modulus ALIF System
Nu Vasive, Incorporated
OVD
Jun 14, 2023K230731Zavation ALIF System
Zavation Medical Products, LLC
OVD
Apr 21, 2023K230808PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System
Kyocera Medical Technologies, Inc.
OVD
Mar 30, 2023K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)
Camber Spine Technologies
OVD
Feb 10, 2023K223413Pisces™-SA STANDALONE ALIF Interbody System
Osseus Fusion Systems
OVD
Feb 7, 2023K223146EVOLUTION SPINE Interbody System
Evolution Spine
OVD
Jan 19, 2023K222554EL CAPITAN Anterior Lumbar Interbody Fusion
Astura Medical
OVD
Nov 22, 2022K222009aprevo® anterior lumbar interbody fusion device with interfixation
Carlsmed, Inc.
OVD
Oct 24, 2022K221545MectaLIF Anterior Extension
Medacta International S.A., CH
OVD
Oct 21, 2022K221751NuVasive Cohere ALIF System Intervertebral Body Fusion Device
Nu Vasive, Incorporated
OVD
Oct 17, 2022K221936Standalone ALIF Interbody Fusion System
Eminent Spine
OVD
Oct 14, 2022K221447Southern Anterior Screw Fixated Cage (SASCA)
Southern Medical (Pty) , Ltd., ZA
OVD
Sep 23, 2022K222561Align
Acuity Surgical Devices, LLC
OVD
May 27, 2022K220610SOLO-L
Aurora Spine, Inc.
OVD
May 13, 2022K220115ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System
MiRus, LLC
OVD

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