U2™ Knee 2303-2231
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04719872163183 | Date22 May 2017 | StatusListed |
| United States | FDA 510(k) | NumberK161705 | Date16 Mar 2017 | StatusActive |
Recalls
-
- Terminated Z-1378-2013
The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- U2™ Knee
- Generic name
- Knee tibia prosthesis trial, reusable
- Model / Ref / Catalog
- 2303-2231
- Primary DI / UDI-DI
- 04719872163183
- 510(k) Number
- FDA product code
- OIY, MBH, JWH
- GMDN term
- Knee tibia prosthesis trial, reusable
- Device class
- Class II
- Regulation number
- 888.3560, 888.3565
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Other devices from United Orthopedic Corp.
Properties
Other properties (11)
- Supplied sterile: No
- Single use: No
- Implantable: No
- Contains latex: No
- Over-the-counter: No
- Convenience kit: No
- Combination product: No
- HCT/P: No
- Premarket exempt: No
- Serial number: No
- Expiration date: No