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
Apr 13, 2018K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime Intervertebral Body Fusi
SeaSpine Orthopedics Corporation
OVD
Mar 29, 2018K173082Arco™-SA Lumbar Cage System
Neurostructures, Inc.
OVD
Feb 12, 2018K172941CASCADIA Interbody System
K2m
OVD
Nov 29, 2017K172019Brisbane ALIF Device, Gladstone ALIF Device
Signature Orthopaedics Pty, Ltd., AU
OVD
Nov 8, 2017K172083Idys™ ALIF System
Clariance, Sas, FR
OVD
Nov 2, 2017K172328SOVEREIGN™ Spinal System
Medtronic Sofamor Danek USA, Inc.
OVD
Sep 25, 2017K170157INDEPENDENCE® Spacers
Globus Medical, Inc.
OVD
Sep 7, 2017K170855T-Rex Standalone ALIF
Siats, LLC
OVD
Aug 28, 2017K171567IRIX-A Lumbar Integrated Fusion System
X-Spine Systems, Inc.
OVD
May 8, 2017K163670Rampart One Lumbar Interbody Fusion Device
Spineology, Inc.
OVD
Apr 26, 2017K170592NuVasive BASE Interfixated Titanium System
Nu Vasive, Incorporated
OVD
Apr 20, 2017K162236Ax Stand-Alone ALIF System
Innovasis, Inc.
OVD
Apr 13, 2017K163269Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device
Titan Spine, LLC
OVD
Mar 16, 2017K170455MectaLIF Anterior Stand Alone
Medacta International S.A., CH
OVD
Feb 28, 2017K163543Biomet Fusion System
Zimmer Biomet Spine, Inc.
OVD
Dec 14, 2016K162680SOVEREIGN® Spinal System
Medtronic Sofamor Danek USA, Inc.
OVD
Dec 1, 2016K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion Device
SeaSpine Orthopedics Corporation
OVD
Nov 22, 2016K161993Leva® Anterior Interbody System
Spine Wave, Inc.
OVD
Sep 29, 2016K161379ELSA Spacers
Globus Medical, Inc.
OVD
Sep 28, 2016K161173Avenue® T TLIF Cage
Ldr Spine USA, Inc.
OVD
Sep 8, 2016K161129PILLAR SA PTC
Orthofix, Inc.
OVD
Aug 29, 2016K160597INDEPENDENCE MIS Spacers
Globus Medical, Inc.
OVD
Jul 21, 2016K160605MectaLIF Anterior Stand-Alone
Medacta International, CH
OVD
Jul 15, 2016K161223TransContinental® M Spacers and InterContinental® Plate-Spacers
Globus Medical, Inc.
OVD
May 3, 2016K153720ENZA Zero-Profile Anterior Interbody Fusion
Camber Spine Technologies
OVD
Apr 20, 2016K160051NuVasive® Interfixated Interbody System
Nu Vasive, Incorporated
OVD
Feb 18, 2016K160291Optimus ALIF System
Amendia, Inc.
OVD
Jan 13, 2016K151312VerteLP Interbody Fusion Device
Vgi, LLC
OVD
Dec 21, 2015K151481Sahara Stabilization System
K2m, Inc.
OVD
Dec 1, 2015K152943NuVasive Foundation-LL System
Nu Vasive, Incorporated
OVD
Aug 21, 2015K150673SYNFIX Evolution Secured Spacer System
Synthes (USA) Products, LLC
OVD
Jun 25, 2015K151214ALIF Interfixated System
Nu Vasive, Incorporated
OVD
Jun 11, 2015K142645Avenue T TLIF Cage
Ldr Spine USA, Inc.
OVD
Jun 8, 2015K150643Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti
Centinel Spine, Inc.
OVD
May 7, 2015K142487Chesapeake Stabilization System
K2m, Inc.
OVD
Feb 26, 2015K143228Ancora LLC Interbody Fusion Device
Frontier Medical Devices, Inc.
OVD
Feb 26, 2015K142498MAGNIFY and MAGNIFY-S Spacers
Globus Medical, Inc.
OVD
Feb 19, 2015K141798SYPHER SPACER SYSTEM
Biogennix, LLC
OVD
Jan 26, 2015K143163AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® A
Stryker Corporation
OVD
Jan 15, 2015K141187IMPIX ALIF S/A
Medicrea International SA, FR
OVD
Dec 19, 2014K142271Zavation Z-Link Lumbar
Zavation, LLC
OVD
Nov 17, 2014K133827A-LINK Z
Osteo Vasive, LLC
OVD
Nov 13, 2014K142066AERO-LL LUMBAR CAGE SYSTEM
Stryker Corporation
OVD
Nov 7, 2014K141942MIDLINE II TI
Centinel Spine, Inc.
OVD
Oct 15, 2014K142095RENOVIS S134 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM
Renovis Surgical Technologies, Inc.
OVD
Oct 9, 2014K141791BIOMET FUSION SYSTEM
Biomet Spine
OVD
Jul 29, 2014K133947IRIX-A LUMBAR INTEGRATED FUSION SYSTEM
X-Spine Systems, Inc.
OVD
Jul 28, 2014K140479COROENT XL-F SYSTEM
Nu Vasive, Incorporated
OVD
Jun 10, 2014K133494CHESAPEAKE SPINAL SYSTEM
K2m, Inc.
OVD
May 30, 2014K133328AERO-AL LUMBAR CAGE SYSTEM
Stryker Corporation
OVD

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