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OVE

165 FDA 510(k) clearances · Product code

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RecordFirmDate
NuVasive® CoRoent® Small Interlock™ System (K161442)Nu Vasive, Incorporated2016-09-28
SeaSpine Shoreline ACS - Anterior Cervical Standalone System (K161081)SeaSpine Orthopedics Corporation2016-09-14
Pro-Link® Stand-Alone Cervical Spacer System (K160066)Life Spine, Inc.2016-09-02
Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System (K153352)Spinal Elements, Inc.2016-08-01
Genesys Spine Apache® Anchored Cervical Interbody Fusion System (K152099)Genesys Spine2016-07-28
Alta ACDF System (K152622)Biomet Spine2016-07-08
Cervical Stand Alone System (K161280)Orthofix, Inc.2016-06-17
ArcadiusXP C Spinal System (K153629)Aesculap Implant Systems, Inc.2016-05-25
Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System (K153250)Renovis Surgical Technologies2016-03-16
COALITION Spacers (K151939)Globus Medical, Inc.2016-01-29
Unison-C Anterior Cervical Fixation System (K152793)Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.2016-01-19
Amendia Stand-Alone Cervical System (K152972)Amendia, Inc.2016-01-14
TOMCAT Cervical Spinal System (K152515)Choicespine, LP2015-12-18
Endoskeleton(r) TCS System (K153122)Titan Spine, LLC2015-12-14
ROI-C Titanium-Coated Implant System (K151934)Ldr Spine USA2015-12-07
Endoskeleton TCS Interbody Fusion Device (K151596)Titan Spine, LLC2015-10-09
LDR Spine ROI-C Cervical Cage System (K150765)Ldr Spine USA2015-09-17
Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System (K151064)Biomet Spine2015-08-12
A-CIFT SoloFuse (K151198)Spinefrontier, Inc.2015-07-17
STALIF C; STALIF C-Ti (K150053)Centinel Spine, Inc.2015-06-24
INCITE ANCHORED CERVICAL INTERBODY DEVICE (K150913)Incite Innovation2015-04-30
SCARLET® AC-T Secured Anterior Cervical Cage (K143214)Spineart2015-02-23
Endoskeleton TCS System (K142940)Titan Spine, LLC2015-01-28
DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM (K141599)Medtronic Sofamor Danek USA, Inc.2015-01-21
Crystal ®; Mosaic ®; Vertu ® (K133218)Spinal Elements, Inc.2014-12-10
CoRoent Small Interlock System (K142299)Nu Vasive, Incorporated2014-11-25
IN:C2 SPINAL FIXATION SYSTME (K141537)Spine Smith Holdings, LLC2014-11-25
STALIF CTI, STALIF C (K142079)Centinel Spine, Inc.2014-10-24
SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION (K141314)Spineart2014-09-29
Z-LINK CERVICAL (K141005)Zavation, LLC2014-08-07
STALIF C(R) (K133200)Centinel Spine, Inc.2014-05-08
CERVICAL STAND ALONE SYSTEM (K132999)Orthofix, Inc.2014-04-14
EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM (K132582)Exactech, Inc.2014-02-12
OPTIO-C ANTERIOR CERVICAL SYSTEM (K132894)Zimmer Spine, Inc.2014-01-16
SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM (K131880)Spinefrontier, Inc.2014-01-03
VAULT-C INTERVERTEBRAL BODY FUSION DEVICE (K132029)Spinal USA2013-11-25
IRIX-C CERVICAL INTEGRATED FUSION SYSTEM (K131951)X-Spine Systems, Inc.2013-08-14
COALITION SPACER (K131449)Globus Medical, Inc.2013-07-30
INCITE ANCHORED CERVICAL INTERBODY DEVICE (K130306)Incite Innovation, LLC2013-04-11
SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM (K122771)Spinal Elements, Inc.2013-01-10
IN:C2 SPINAL FIXATION SYSTEM (K122630)Spine Smith Partners L.P.2012-12-05
PRO-LINK CERVICAL SPACER SYSTEM (K121151)Life Spine, Inc.2012-11-16
INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE (K122008)Incite Innovation, LLC2012-11-16
STALIF C (K120819)Centinel Spine, Inc.2012-08-31
SYNTHES ZERO-P VARIABLE ANGLE (VA) (K121852)Synthes Spine Co.Lp2012-07-25
SOLITAIRE-C CERVICAL SPACER SYSTEM (K113796)Ebi, LLC2012-04-26
PEEK PREVAIL CERVICAL INTERBODY DEVICE (K113252)Medtronic Sofamor Danek2012-01-17
LANX CERVICAL SA (K112388)Lanx, Inc.2011-12-16
SYNTHES ZERO-P (K112459)Synthes Spine Co.Lp2011-12-12
RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM (K111272)Rhausler, Inc.2011-11-29
SYNTHES ZERO-P VARIABLE ANGLE (VA) (K112068)Synthes Spine Co.Lp2011-11-07
CHESAPEAKE (CERVICAL COMPONENTS) (K111439)K2m, Inc.2011-08-24
AVS ANCHOR-C CERVICAL CAGE SYSTEM (K102606)Stryker Spine2011-04-22
COROENT INTERLOCK SYSTEM (K102547)Nuvasive, Inc.2011-02-07
ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL (K101588)Apollo Spine, Inc.2011-01-07
SYNTHES ZERO-P (K093762)Synthes Spine2010-12-20
CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE (K102323)Theken Spine, LLC2010-12-16
PEEK PREVAIL CERVICAL INTERBODY DEVICE (K094042)Medtronic Sofamor Danek2010-06-30
ZUMA-C (K092521)Seaspine, Inc.2010-04-13
COALITION SPACER (K083389)Globus Medical, Inc.2009-03-26
INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD) (K081194)Rsb Spine, LLC2008-05-29
PEEK PREVAIL CERVICAL INTERBODY DEVICE (K073285)Medtronic Sofamor Danek USA, Inc.2008-05-15
SYNTHES ZERO-P (K072981)Synthes Spine Co.Lp2008-02-11
STALIF (TM) C (K072415)Surgicraft , Ltd.2008-01-25
MOSAIC DEVICES (K071833)Spinal Elements, Inc.2007-10-23
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