Identity
- Trade Name
- ROI-C FDA UDI
- Generic Name
- Metal-polymer composite spinal interbody fusion cage FDA UDI
- Device Name
- ROI-C COATED IMPLANT 12x15,5 H5 FDA UDI
- Model / Reference
- CMC1351P FDA UDI
- Description
- ROI-C COATED IMPLANT 12x15,5 H5 FDA UDI
Identifiers
- Catalog Number
- CMC1351P FDA UDI
- Primary DI / UDI-DI
- 03662663023313 FDA UDI
- FDA Product Code
- OVE FDA UDI
- GMDN Term
- Metal-polymer composite spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Dimensions & Sizes
- Size
- Height — 5 Millimeter FDA UDIDepth — 12 Millimeter FDA UDIWidth — 15.5 Millimeter FDA UDI
Category: Metal-polymer composite spinal interbody fusion cage
Roi-C by Ldr Spine USA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Metal-polymer composite spinal interbody fusion cage.
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- MIDLINE II-Ti — Centinel Spine, LLC · Class II
- Latitude-C Cervical Interbody Spacer System — Degen Medical · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ldr Spine USA
Sources (1)
- FDA UDI 0f6ba7fe-f37c-4fa6-91e8-3a11931cd7c9 36 fields · synced May 30, 2026