Unity Total Knee System 123.028.00
by Corin Ltd
Unity Total Knee System 123.028.00 is a Class II device made by Corin Ltd, cleared under FDA 510(k) K170808 on 13 Jul 2017 and listed in FDA GUDID since 16 Oct 2018 (UDI-DI 05055343884287), 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 | Number05055343884287 | Date16 Oct 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170808 | Date13 Jul 2017 | StatusActive |
Official records
- AccessGUDID record 05055343884287
- FDA 510(k) database K170808
Across registries
- FDA 510(k) K170808 decided 13 Jul 2017 Active
- FDA GUDID UDI-DI 05055343884287 listed 16 Oct 2018 Listed
Timeline
- Cleared FDA 510(k) K170808
- Listed FDA GUDID 05055343884287
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Unity Total Knee System
- Generic name
- Orthopaedic implant aiming/guiding block, reusable
- Model / Ref / Catalog
- 123.028.00
- Primary DI / UDI-DI
- 05055343884287
- 510(k) Number
- FDA product code
- JWH
- GMDN term
- Orthopaedic implant aiming/guiding block, reusable
- Device class
- Class II
- Regulation number
- 888.3560
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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