ClearanceBrief
Panels › Orthopedic › Product code ODP · Class 2

Intervertebral Fusion Device With Bone Graft, Cervical

Regulation 888.3080

24510(k)s in 12 months (354 all time)
2recalls in 12 months (11 all time)
9recalls that name a 510(k)
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Top companies in ODP

Decided510(k)Device and applicantCode
Aug 15, 2014K141129EXACTECH CERVICAL SPACER SYSTEM
Exactech, Inc.
ODP
Jul 28, 2014K140921COROENT SMALL INTERBODY SYSTEM
Nu Vasive, Incorporated
ODP
Jul 22, 2014K140864VELOXTM INTERBODY FUSION SYSTEM
U&I Corp., KR
ODP
Jul 18, 2014K132732MEDYSSEY ANTERIOR CERVICAL FUSION CAGE
Medyssey USA, Inc.
ODP
Jul 7, 2014K133784VISTA-S DEVICE, ASSOCIATED INSTRUMENTATION
Zimmer Trabecular Metal Technology
ODP
May 5, 2014K140066INFILL CERVICAL
Pinnacle Spine Group, LLC
ODP
Apr 28, 2014K133653ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM
Medtronic Sofamor Danek USA, Inc.
ODP
Apr 16, 2014K133815INTESS CERVICAL CAGE SYSTEM
Kalitec Direct, LLC
ODP
Apr 3, 2014K140003COROENT SMALL INTERBODY SYSTEM
Nuvasive, Inc.
ODP
Apr 2, 2014K132483INNESIS PEEK CERVICAL CAGE
Bk Meditech, Co., Ltd.
ODP
Mar 20, 2014K133529CAMBER SPINE COVERIS CERVICAL CAGE
Camber Spine
ODP
Mar 5, 2014K132926VELOFIXTM INTERBODY FUSION SYSTEM
U&I Corp., KR
ODP
Feb 12, 2014K132991C-BOX PEEK CERVICAL IBF
Innovasis, Inc.
ODP
Feb 10, 2014K133623C-PLUS
Pioneer Surgical Technology, Inc.
ODP
Jan 9, 2014K133321ALAMO C
Alliance Partners, LLC
ODP
Dec 11, 2013K130317GENESYS SPINE APACHE IBFD STAR CERVICAL SYSTEM
Genesys Spine
ODP
Dec 4, 2013K132584PERIMETER C SPINAL SYSTEM
Medtronic Sofamor Danek USA, Inc.
ODP
Nov 18, 2013K132718INTEGRITY SPINE CORE SYSTEM
Integrity Spine
ODP
Nov 13, 2013K130853IDYS(TM) C
Clariance
ODP
Sep 30, 2013K130573TYBER MEDICAL INTERBODY SYSTEM; ACIF, ALIF, PLIF, TLIF, DLIF
Tyber Medical, LLC
ODP
Sep 23, 2013K131429RELIANCE CERVICAL IBF SYSTEM
Reliance Medical Systems, LLC
ODP
Sep 23, 2013K130177ANATOMIC PEEK CERVICAL FUSION SYSTEM
Medtronic Sofamor Danek USA, Inc.
ODP
Aug 14, 2013K130948C-FUSE CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
Southern Spine, LLC
ODP
Jul 5, 2013K121178TRANSCORP ACIF SYSTEM
Transcorp, Inc.
ODP
Jun 12, 2013K122588VUSION CS PLUS
Ortho Development Corp.
ODP
May 24, 2013K122801PROVIDENCE CERVICAL CAGE
Providence Medical Technology, Inc.
ODP
Apr 15, 2013K123909AESCULAP CESPACE XP
Aesculap Implant System, Inc.
ODP
Mar 28, 2013K122850TALOS-C CERVICAL INTERVERTEBRAL BODY FUSION DEVICES
Meditech Advisors, LLC
ODP
Feb 28, 2013K122872INTERVERTEBRAL BODY FUSION DEVICE
Dio Medical Co., Ltd.
ODP
Feb 15, 2013K122518SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE
Bm Korea Co., Ltd.
ODP
Feb 7, 2013K123206MAXIM SURGICAL X-TREME INTERBODY FUSION SYSTEM
Maxim Surgical
ODP
Jan 29, 2013K120603VARILIFT -C
Wenzel Spine
ODP
Jan 4, 2013K123388K7C SPACER
K7, LLC
ODP
Nov 29, 2012K121649CONSTRUX MINI PEEK TI SPACER SYSTEM
Orthofix
ODP
Oct 18, 2012K1217414-WEB CERVICAL STS (SPINAL TRUSS SYSTEM)
4-Web, Inc.
ODP
Oct 17, 2012K122085STINGRAY CERVICAL CAGE
Omni Surgical, LP Dba Spine360
ODP
Oct 4, 2012K122366TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE
Spineart, CH
ODP
Aug 30, 2012K122444CERVICAL CAGE
Eisertech, LLC
ODP
Aug 20, 2012K120486AVS AS PEEK SPACER
Stryker Spine
ODP
Aug 10, 2012K121320C7 ANTERIOR CERVICAL INTERVERTEBRAL FUSION CAGE
Medyssey Co, Ltd.
ODP
Jul 27, 2012K121569MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM
Accel Spine
ODP
Jun 13, 2012K120345HONOUR SPACER SYSTEM
Nexxt Spine, LLC
ODP
May 25, 2012K120275SYNTHES ACIS/VERTEBRAL SPACER CR
Synthes (Usa), LLC
ODP
May 24, 2012K120840LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM
L&K BIOMED Co., Ltd., KR
ODP
May 8, 2012K120396RELIANCE CERVICAL IBF SYSTEM
Reliance Medical Systems, LLC
ODP
May 1, 2012K112801AYERS ROCK CERVICAL CAGE
Qualgenix
ODP
Apr 26, 2012K120517DEPUY PULSE CERVICAL CAGE SYSTEM
Medos International SARL
ODP
Mar 14, 2012K111820SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE
Bm Korea Co., Ltd.
ODP
Feb 16, 2012K120143ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
Apollo Spine
ODP
Feb 16, 2012K113518ARENA-C CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
Spinefrontier, Inc.
ODP

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