IlluminOss CT-0307
IlluminOss CT-0307 is a Class II device made by IlluminOss Medical, granted FDA De Novo DEN160062 on 19 Dec 2017 and listed in FDA GUDID since 11 Mar 2022 (UDI-DI M986CT03070), active as of 8 Nov 2026.
Active
De Novo
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberM986CT03070 | Date11 Mar 2022 | StatusListed |
| United States | FDA De NovoDENG | NumberDEN160062 | Date19 Dec 2017 | StatusActive |
Official records
- FDA De Novo database DEN160062
Across registries
- FDA De Novo DEN160062 decided 19 Dec 2017 Active
- FDA GUDID UDI-DI M986CT03070 listed 11 Mar 2022 Listed
Timeline
- Granted FDA De Novo DEN160062
- Listed FDA GUDID M986CT03070
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- Trade name
- IlluminOss
- Generic name
- Orthopaedic bone pin, non-bioabsorbable
- Model / Ref / Catalog
- CT-0307
- Primary DI / UDI-DI
- M986CT03070
- De Novo Number
- FDA product code
- QAD, LXH
- GMDN term
- Orthopaedic bone pin, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3023, 888.4540
- GUDID distribution status
- In Commercial Distribution
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