Cori ROB10101
Cori ROB10101 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K221224 on 19 Aug 2022 and listed in FDA GUDID since 14 Dec 2022 (UDI-DI 00885556809655), active as of 23 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 | Number00885556809655 | Date14 Dec 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK221224 | Date19 Aug 2022 | StatusActive |
Official records
- AccessGUDID record 00885556809655
- FDA 510(k) database K221224
Across registries
- FDA 510(k) K221224 decided 19 Aug 2022 Active
- FDA GUDID UDI-DI 00885556809655 listed 14 Dec 2022 Listed
Timeline
- Cleared FDA 510(k) K221224
- Listed FDA GUDID 00885556809655
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cori
- Generic name
- Orthopaedic knee-balance analyser electrical cable/analogue-to-digital converter
- Model / Ref / Catalog
- ROB10101
- Primary DI / UDI-DI
- 00885556809655
- 510(k) Number
- FDA product code
- OLO
- GMDN term
- Orthopaedic knee-balance analyser electrical cable/analogue-to-digital converter
- Device class
- Class II
- Regulation number
- 882.4560
- GUDID distribution status
- In Commercial Distribution
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