Home › Device types › OVE
Intervertebral Fusion Device With Integrated Fixation, Cervical
FDA product code OVE · Class 2 · Orthopedic
17,973
Registered devices
2,405
Adverse events
12
Recalls
169
510(k) clearances
Devices with this code
DOLOMITE — Astura MedicalOmnia Medical TiBrid™-SC — OMNIA MEDICAL, LLCHiJAK™ Stand Alone — ATLAS SPINE, INC.TOMCAT Cervical Spinal System — Choice Spine, LPCYLOX ST 8° — SIGNUS Medizintechnik GmbHCONDUIT ZERO-P VA — Avalign Technologies, Inc.Velofix™ SA Cervical Cage — CG MedTech Co.,Ltd.STALIF C — Centinel Spine, LLCCoRoent — Nuvasive, Inc.Solitaire®-C Cervical Spacer — BIOMET SPINE LLCE3D®-C Interbody System — Evolution Spine LLCCOALITION — GLOBUS MEDICAL, INC.Tranquil-C Interbody System — NEXUS SPINE, L.L.C.A-CIFT — SPINEFRONTIER, INC.IdentiTi — ALPHATEC SPINE, INC.IdentiTi — ALPHATEC SPINE, INC.CoRoent — Nuvasive, Inc.DOLOMITE — Astura MedicalShoreline ACS — Seaspine Orthopedics CorporationUnison™-C Anterior Cervical Fixation System — Pioneer Surgical Technology, Inc.Optio-C® — ZIMMER SPINE, INC.ROI-C — LDR Spine Usa, Inc.E3D®-C Interbody System — Evolution Spine LLCE3D®-C Interbody System — Evolution Spine LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-23 | Stryker Spine | Labeling Correction: Instructions For Use (IFU)-Updated electronic Rev 5, specific language for indications for use for the United States and Canada was inadve |
| 2021-09-08 | K2M, Inc | Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requi |
| 2021-09-02 | Medtronic Sofamor Danek USA Inc | Engraving on implants may not match what is listed on the pouch labels. |
| 2019-06-13 | SpineFrontier, Inc. | There is a potential for the driver to bind up when attempting to advance the intervertebral body fixation screw. |
| 2019-01-30 | U&I CORP. | The vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. A possibility exists of screw pullout, lo |
| 2017-07-07 | Amendia, Inc | Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws. Although the laser mark and color identify the sc |
| 2016-11-22 | Amendia, Inc | Absent tantalum market pin. |
| 2015-09-28 | Exactech, Inc. | Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella One Interbody Fusion Device Lordotic (05-090-01-1610) were pack |
| 2015-07-20 | TITAN SPINE, LLC | Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to the locking bone screw collars not 'locking'. |
| 2015-02-20 | TITAN SPINE, LLC | The TCS Straight Hexlobular #6 Drivers (5210-1004) tip sheared off during use in procedures that involved patients with dense bones. As a result of this malfun |
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