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
May 6, 2022K213935PISCES-SA Standalone ALIF Interbody System
Osseus Fusion Systems
OVD
Apr 19, 2022K211837Altus Spine Interbody Standalone Fusion System
Altus Partners, LLC
OVD
Apr 1, 2022K213118Dakota ALIF System
Precision Spine, Inc.
OVD
Mar 30, 2022K214047EL CAPITAN Anterior Lumbar Interbody Fusion System
Astura Medical
OVD
Mar 18, 2022K212498Stable-L Standalone Lumbar Interbody System
Nexus Spine, LLC
OVD
Jan 7, 2022K212980Tesera-k ALIF System
Kyocera Medical Technologies, Inc.
OVD
Oct 15, 2021K212967AxTiHA Stand-Alone ALIF System
Innovasis, Inc.
OVD
Sep 29, 2021K210590Axis Spine Technologies ALIF
Axis Spine Technologies, Ltd., GB
OVD
Sep 7, 2021K211769OneLIF Intervertebral Body Replacement System
Novapproach Spine
OVD
May 4, 2021K201671A-Link Z
Acuity Surgical Devices, LLC
OVD
Apr 9, 2021K203742IdentiTi ALIF Standalone Interbody System
Alphatec Spine, Inc.
OVD
Apr 1, 2021K202032Idys LLIF 3DTi
Clariance, Sas, FR
OVD
Mar 1, 2021K210271NuVasive Modulus ALIF System
Nu Vasive, Incorporated
OVD
Dec 23, 2020K203207Omnia Medical TiBrid-SA
Omnia Medical, LLC
OVD
Dec 15, 2020K202230NEXXT MATRIXX Stand Alone ALIF System
Nexxt Spine, LLC
OVD
Oct 2, 2020K202190Oculus-SA Lumbar Cage System
Neurostructures
OVD
Aug 10, 2020K201585Monterey AL Interbody System
Stryker Corporation
OVD
Jul 31, 2020K201087CORBEL Spacers
Globus Medical, Inc.
OVD
May 29, 2020K200002Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device
4Web, Inc.
OVD
May 20, 2020K200352Axis Spine Technologies ALIF
Axis Spine Technologies, Ltd., GB
OVD
Apr 28, 2020K200541Hive™ Stand-alone Anterior Lumbar Interbody System
Hd Lifesciences, LLC
OVD
Apr 21, 2020K192492EL CAPITAN Anterior Lumber Interbody System
Astura Medical, LLC
OVD
Apr 17, 2020K200338ProLift Lateral Fixated
Life Spine, Inc.
OVD
Mar 25, 2020K193593NuVasive 3DP Interfixated ALIF System
Nu Vasive, Incorporated
OVD
Feb 4, 2020K193320KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System
Kyocera Medical Technologies, Inc.
OVD
Jan 22, 2020K192993SCARLET AL-T
Spineart, CH
OVD
Jan 8, 2020K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device
Titan Spine, Inc.
OVD
Dec 16, 2019K191834Stand-Alone ALIF Titanium System
Life Spine, Inc.
OVD
Nov 4, 2019K192168Idys ALIF ZP 3DTi
Clariance, Sas, FR
OVD
Oct 3, 2019K190179SAHARA Stabilization System
K2m, Inc.
OVD
Aug 29, 2019K192054Endoskeleton TAS Plate
Titan Spine, Inc.
OVD
Aug 23, 2019K192047Rampart™ One Lumbar Interbody Fusion System
Spineology, Inc.
OVD
Jun 21, 2019K182139AXTi Titanium Stand-Alone ALIF System
Innovasis, Inc.
OVD
Jun 6, 2019K191263Idys ALIF TiVac
Clariance, Sas, FR
OVD
May 29, 2019K190877Juliet® Ti LL Lumbar Interbody Device
Spineart, CH
OVD
May 23, 2019K191091Rampart One Lumbar Interbody Fusion System
Spineology, Inc.
OVD
Mar 15, 2019K183426MectaLIF Anterior Stand Alone Extension
Medacta International S.A., CH
OVD
Jan 15, 2019K181096Avenue P Cage System
Zimmer Biomet Spine, Inc.
OVD
Jan 9, 2019K181118Reliance Lumbar IBF System
Reliance Medical Systems
OVD
Dec 7, 2018K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System
Renovis Surgical Technologies
OVD
Nov 9, 2018K182195Arco™-SA Lumbar Cage System
Neurostructures, Inc.
OVD
Oct 9, 2018K181818Scarlet AL-T
Spineart, CH
OVD
Sep 13, 2018K180215DYNA-LINK ELITE Stand-Alone Anterior Lumbar System
Life Spine, Inc.
OVD
Aug 24, 2018K181386NuVasive Brigade Lateral System
Nu Vasive, Incorporated
OVD
Aug 10, 2018K180814CoreLink® M3™ Stand-Alone Anterior Lumbar System
Corelink, LLC
OVD
Jul 12, 2018K180695FBC 921 (ALIF)
Fbc Device Aps, DK
OVD
Jun 14, 2018K180502S128 Anterior Lumbar Interbody Fusion (ALIF) System
Renovis Surgical Technologies, Inc.
OVD
May 16, 2018K180519HARRIER-SA™ Lumbar Interbody System
Choicespine, LP
OVD
Apr 25, 2018K180002Rampart One Lumbar Interbody Fusion Device
Spineology, Inc.
OVD
Apr 18, 2018K173432ENZA-A Titanium ALIF
Camber Spine Technologies
OVD

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