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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
DateFirm and productCodeLinked 510(k)
Sep 23, 2024Stryker Spine
AVS Anchor-C Cervical Cage System Instructions For Use (IFU)- eIFU (revision 5)-Indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at
Open, Classified		 OVEK102606
Sep 8, 2021K2M, Inc
Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
Terminated		 OVEK142487
Sep 2, 2021Medtronic Sofamor Danek USA Inc
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Terminated		 OVEK151596
K153122 +4
Jun 13, 2019SpineFrontier, Inc.
A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106)
Terminated		 OVEK172484
Jan 30, 2019U&I CORP.
Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion pro
Terminated		 OVEK172424
Jul 7, 2017Amendia, Inc
Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System.
Terminated		 OVEK152972
Jan 9, 2017Amendia, Inc
Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with
Terminated		 OVEK152972
Feb 13, 2016Exactech, Inc.
Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion
Terminated		 OVEK132582
Aug 3, 2015TITAN SPINE, LLC
Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the Endoskeleton TCS Interbody Fusion Device, spinal implant. Part Numbers / Product Description: 5302-3514 / 03.5 x 14mm Locki
Terminated		 OVEK142940
Mar 26, 2015TITAN SPINE, LLC
Endo TCS Driver Straight Hexalobe #6 P/N 5210-1004, Non-Sterile, Manufactured by Titan Spine, LLC. Endo TCS driver is one of the instruments within the surgical tray for use with the Interbody Fusion
Terminated		 OVEK142940
Dec 24, 2014Ebi, Llc
Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict moti
Terminated		 OVEK113796
Dec 5, 2013Synthes USA HQ, Inc.
Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indicated for use in skele
Terminated		 OVEK112068

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