ClearanceBrief
Panels › Orthopedic › Product code OVE · Class 2

Intervertebral Fusion Device With Integrated Fixation, Cervical

Regulation 888.3080

15510(k)s in 12 months (169 all time)
0recalls in 12 months (12 all time)
12recalls that name a 510(k)
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Top companies in OVE

Company510(k)sRecalls
SeaSpine Orthopedics Corporation80
Genesys Spine60
Titan Spine, Inc.42
Medtronic Sofamor Danek41
Synthes Spine50
4Web Medical40
Centinel Spine, Inc.40
Elevation Spine40
Globus Medical, Inc.40
Life Spine, Inc.40
Decided510(k)Device and applicantCode
Feb 16, 2017K162760Spine Wave Anterior Cervical Spine System
Spine Wave, Inc.
OVE
Dec 29, 2016K162531STERISPINE CC
Safe Orthopaedics, FR
OVE
Nov 7, 2016K162944Irix-C Cervical Integrated Fusion System
X-Spine Systems, Inc.
OVE
Oct 21, 2016K160313Xenco Medical Cervical Interbody System
Xenco Medical, LLC
OVE
Sep 28, 2016K161442NuVasive® CoRoent® Small Interlock™ System
Nu Vasive, Incorporated
OVE
Sep 14, 2016K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone System
SeaSpine Orthopedics Corporation
OVE
Sep 2, 2016K160066Pro-Link® Stand-Alone Cervical Spacer System
Life Spine, Inc.
OVE
Aug 1, 2016K153352Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System
Spinal Elements, Inc.
OVE
Jul 28, 2016K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion System
Genesys Spine
OVE
Jul 8, 2016K152622Alta ACDF System
Biomet Spine
OVE
Jun 17, 2016K161280Cervical Stand Alone System
Orthofix, Inc.
OVE
May 25, 2016K153629ArcadiusXP C Spinal System
Aesculap Implant Systems, Inc.
OVE
Mar 16, 2016K153250Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System
Renovis Surgical Technologies
OVE
Jan 29, 2016K151939COALITION Spacers
Globus Medical, Inc.
OVE
Jan 19, 2016K152793Unison-C Anterior Cervical Fixation System
Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.
OVE
Jan 14, 2016K152972Amendia Stand-Alone Cervical System
Amendia, Inc.
OVE
Dec 18, 2015K152515TOMCAT Cervical Spinal System
Choicespine, LP
OVE
Dec 14, 2015K153122Endoskeleton(r) TCS System
Titan Spine, LLC
OVE
Dec 7, 2015K151934ROI-C Titanium-Coated Implant System
Ldr Spine USA
OVE
Oct 9, 2015K151596Endoskeleton TCS Interbody Fusion Device
Titan Spine, LLC
OVE
Sep 17, 2015K150765LDR Spine ROI-C Cervical Cage System
Ldr Spine USA
OVE
Aug 12, 2015K151064Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System
Biomet Spine
OVE
Jul 17, 2015K151198A-CIFT SoloFuse
Spinefrontier, Inc.
OVE
Jun 24, 2015K150053STALIF C; STALIF C-Ti
Centinel Spine, Inc.
OVE
Apr 30, 2015K150913INCITE ANCHORED CERVICAL INTERBODY DEVICE
Incite Innovation
OVE
Feb 23, 2015K143214SCARLET® AC-T Secured Anterior Cervical Cage
Spineart, CH
OVE
Jan 28, 2015K142940Endoskeleton TCS System
Titan Spine, LLC
OVE
Jan 21, 2015K141599DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM
Medtronic Sofamor Danek USA, Inc.
OVE
Dec 10, 2014K133218Crystal ®; Mosaic ®; Vertu ®
Spinal Elements, Inc.
OVE
Nov 25, 2014K142299CoRoent Small Interlock System
Nu Vasive, Incorporated
OVE
Nov 25, 2014K141537IN:C2 SPINAL FIXATION SYSTME
Spine Smith Holdings, LLC
OVE
Oct 24, 2014K142079STALIF CTI, STALIF C
Centinel Spine, Inc.
OVE
Sep 29, 2014K141314SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION
Spineart, CH
OVE
Aug 7, 2014K141005Z-LINK CERVICAL
Zavation, LLC
OVE
May 8, 2014K133200STALIF C(R)
Centinel Spine, Inc.
OVE
Apr 14, 2014K132999CERVICAL STAND ALONE SYSTEM
Orthofix, Inc.
OVE
Feb 12, 2014K132582EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM
Exactech, Inc.
OVE
Jan 16, 2014K132894OPTIO-C ANTERIOR CERVICAL SYSTEM
Zimmer Spine, Inc.
OVE
Jan 3, 2014K131880SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM
Spinefrontier, Inc.
OVE
Nov 25, 2013K132029VAULT-C INTERVERTEBRAL BODY FUSION DEVICE
Spinal USA
OVE
Aug 14, 2013K131951IRIX-C CERVICAL INTEGRATED FUSION SYSTEM
X-Spine Systems, Inc.
OVE
Jul 30, 2013K131449COALITION SPACER
Globus Medical, Inc.
OVE
Apr 11, 2013K130306INCITE ANCHORED CERVICAL INTERBODY DEVICE
Incite Innovation, LLC
OVE
Jan 10, 2013K122771SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
Spinal Elements, Inc.
OVE
Dec 5, 2012K122630IN:C2 SPINAL FIXATION SYSTEM
Spine Smith Partners L.P.
OVE
Nov 16, 2012K122008INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE
Incite Innovation, LLC
OVE
Nov 16, 2012K121151PRO-LINK CERVICAL SPACER SYSTEM
Life Spine, Inc.
OVE
Aug 31, 2012K120819STALIF C
Centinel Spine, Inc.
OVE
Jul 25, 2012K121852SYNTHES ZERO-P VARIABLE ANGLE (VA)
Synthes Spine Co.Lp
OVE
Apr 26, 2012K113796SOLITAIRE-C CERVICAL SPACER SYSTEM
Ebi, LLC
OVE

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