Identity
- Trade Name
- MATISSE NITRO FDA UDI
- Generic Name
- Ceramic spinal interbody fusion cage FDA UDI
- Device Name
- STERILE, MATISSE ACIF Cage, Si3N4, W14xL12, 10°, 9mm FDA UDI
- Model / Reference
- S.213.4239 FDA UDI
- Description
- STERILE, MATISSE ACIF Cage, Si3N4, W14xL12, 10°, 9mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841732146020 FDA UDI
- FDA Product Code
- ODP FDA UDIMAX FDA UDIOVE FDA UDI
- GMDN Term
- Ceramic 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
Yes
FDA UDI
Category: Ceramic spinal interbody fusion cage
Matisse Nitro by CTL Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- CTL Medical Corporation
Sources (1)
- FDA UDI 7330753b-6cb6-4cb6-afd9-a6064d9fd6f3 33 fields · synced May 30, 2026