Home › Device types › OVE
Intervertebral Fusion Device With Integrated Fixation, Cervical
FDA product code OVE · Class 2 · Orthopedic
17,643
Registered devices
2,375
Adverse events
12
Recalls
165
510(k) clearances
Devices with this code
CoRoent — Nuvasive, Inc.Shoreline ACS — Seaspine Orthopedics CorporationROI-C — LDR Spine Usa, Inc.DOLOMITE — Astura MedicalCoRoent — Nuvasive, Inc.SOLITAIRE-C CERVICAL SPACER — BIOMET SPINE LLCTranquil-C Interbody System — NEXUS SPINE, L.L.C.Trial Head 14x15x7 0 deg. — ELEVATION SPINE, INC.DOLOMITE — Astura MedicalStable-C™ — NEXUS SPINE, L.L.C.AIS-C Standalone System — Genesys Orthopedics Systems LLCE3D-C Interbody System — Evolution Spine LLCKyocera Medical Technologies, Inc. — KYOCERA MEDICAL TECHNOLOGIES, INC.Kyocera Medical Technologies, Inc. — KYOCERA MEDICAL TECHNOLOGIES, INC.CHESAPEAKE® Stabilization System — VB Spine LLCAlta™ Stand-Alone Interbody Fusion System — BIOMET SPINE LLCHexanium® ACIF — SPINEVISIONIdentiTi — ALPHATEC SPINE, INC.Irix-C Cervical Integrated Fusion System — Xtant Medical Holdings, Inc.IDYS-C® ZP 3DTi — CLARIANCETranquil-C Interbody System — NEXUS SPINE, L.L.C.STALIF C-Ti — Centinel Spine, Inc.TrellOss®-C SA — NEXXT SPINE, LLCDOLOMITE — Astura Medical
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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