Roi-C CMC1351P
Roi-C CMC1351P is a Class II device made by Ldr Spine USA, listed in FDA GUDID since 13 Apr 2017 (UDI-DI 03662663023313), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number03662663023313 | Date13 Apr 2017 | StatusListed |
Official records
- AccessGUDID record 03662663023313
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- Roi-C
- Generic name
- Metal-polymer composite spinal interbody fusion cage
- Model / Ref / Catalog
- CMC1351P
- Primary DI / UDI-DI
- 03662663023313
- FDA product code
- OVE
- GMDN term
- Metal-polymer composite spinal interbody fusion cage
- Device class
- Class II
- Regulation number
- 888.3080
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Size
- Height — 5 MillimeterDepth — 12 MillimeterWidth — 15.5 Millimeter
Similar devices
Other devices filed under FDA product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical).
- Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device by 4Web Medical, Inc.
- ACDF Stand Alone Cervical 03.18.305 by Medacta International SA
- ACDF Stand Alone Cervical 03.18.319 by Medacta International SA
- Genesys Spine AIS-C Cervical Anchored Interbody System by Genesys Spine
- IdentiTi Cervical Standalone Interbody System by ALPHATEC SPINE, INC.
- COALITION Spacers by GLOBUS MEDICAL, INC.
- SPIRA-C Integrated Fixation System by CAMBER SPINE TECHNOLOGIES
- SeaSpine WaveForm, C Interbody System by SeaSpine Orthopedics Corporation
- SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM by SPINEFRONTIER, INC.
- SAGI Cervical Cage System by ZheJiang Decans Medical Devices Co., Ltd.