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)
Top companies in OVE
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2024 | Stryker 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 |
OVE | K102606 |
| Sep 8, 2021 | K2M, Inc Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068 Terminated |
OVE | K142487 |
| Sep 2, 2021 | Medtronic Sofamor Danek USA Inc Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm Terminated |
OVE | K151596 K153122 +4 |
| Jun 13, 2019 | SpineFrontier, Inc. A-CIFT SoloFuse Fixed Angle Driver, Model Number 13-32101-01 (Component Part Numbers 14-32107-01 and 14-32106) Terminated |
OVE | K172484 |
| Jan 30, 2019 | U&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 |
OVE | K172424 |
| Jul 7, 2017 | Amendia, 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 |
OVE | K152972 |
| Jan 9, 2017 | Amendia, 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 |
OVE | K152972 |
| Feb 13, 2016 | Exactech, 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 |
OVE | K132582 |
| Aug 3, 2015 | TITAN 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 |
OVE | K142940 |
| Mar 26, 2015 | TITAN 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 |
OVE | K142940 |
| Dec 24, 2014 | Ebi, 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 |
OVE | K113796 |
| Dec 5, 2013 | Synthes 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 |
OVE | K112068 |
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