Colosseum 656.104
Colosseum 656.104 is a Class II device made by Globus Medical, Inc., cleared under FDA 510(k) K190147 on 8 May 2019 and listed in FDA GUDID since 25 Dec 2019 (UDI-DI 00889095977462), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00889095977462 | Date25 Dec 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190147 | Date8 May 2019 | StatusActive |
Official records
- AccessGUDID record 00889095977462
- FDA 510(k) database K190147
Across registries
- FDA 510(k) K190147 decided 8 May 2019 Active
- FDA GUDID UDI-DI 00889095977462 listed 25 Dec 2019 Listed
Timeline
- Cleared FDA 510(k) K190147
- Listed FDA GUDID 00889095977462
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Colosseum
- Generic name
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Model / reference
- 656.104
- Primary DI / UDI-DI
- 00889095977462
- 510(k) Number
- FDA product code
- MQP, PLR
- GMDN term
- Orthopaedic surgical procedure kit, non-medicated, reusable
- Device class
- Class II
- Regulation number
- 888.3060
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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