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
Jan 17, 2012K113252PEEK PREVAIL CERVICAL INTERBODY DEVICE
Medtronic Sofamor Danek
OVE
Dec 16, 2011K112388LANX CERVICAL SA
Lanx, Inc.
OVE
Dec 12, 2011K112459SYNTHES ZERO-P
Synthes Spine Co.Lp
OVE
Nov 29, 2011K111272RHAUSLER PLAGE ANTERIOR CERVICAL FUSION SYSTEM
Rhausler, Inc.
OVE
Nov 7, 2011K112068SYNTHES ZERO-P VARIABLE ANGLE (VA)
Synthes Spine Co.Lp
OVE
Aug 24, 2011K111439CHESAPEAKE (CERVICAL COMPONENTS)
K2m, Inc.
OVE
Apr 22, 2011K102606AVS ANCHOR-C CERVICAL CAGE SYSTEM
Stryker Spine
OVE
Feb 7, 2011K102547COROENT INTERLOCK SYSTEM
Nuvasive, Inc.
OVE
Jan 7, 2011K101588ECLIPSE VERTEBRAL SPACER SYSTEM-CERVICAL
Apollo Spine, Inc.
OVE
Dec 20, 2010K093762SYNTHES ZERO-P
Synthes Spine
OVE
Dec 16, 2010K102323CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE
Theken Spine, LLC
OVE
Jun 30, 2010K094042PEEK PREVAIL CERVICAL INTERBODY DEVICE
Medtronic Sofamor Danek
OVE
Apr 13, 2010K092521ZUMA-C
Seaspine, Inc.
OVE
Mar 26, 2009K083389COALITION SPACER
Globus Medical, Inc.
OVE
May 29, 2008K081194INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD)
Rsb Spine, LLC
OVE
May 15, 2008K073285PEEK PREVAIL CERVICAL INTERBODY DEVICE
Medtronic Sofamor Danek USA, Inc.
OVE
Feb 11, 2008K072981SYNTHES ZERO-P
Synthes Spine Co.Lp
OVE
Jan 25, 2008K072415STALIF (TM) C
Surgicraft , Ltd.
OVE
Oct 23, 2007K071833MOSAIC DEVICES
Spinal Elements, Inc.
OVE

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