U2 Bipolar Implant 1503-4249
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04719872178781 | Date1 Nov 2022 | StatusListed |
Recalls
-
- Terminated Z-1383-2013
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- Withdrawn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 — GUDID listing Listed
Specification
- Trade Name
- U2 Bipolar Implant
- Generic Name
- Acetabulum prosthesis trial, prefabricated, reusable
- Model / Ref / Catalog
- 1503-4249
- Primary DI / UDI-DI
- 04719872178781
- 510(k) Number
- FDA Product Code
- KWY
- GMDN Term
- Acetabulum prosthesis trial, prefabricated, reusable
- Device Class
- Class II
- Regulation Number
- 888.3390
- GUDID distribution status
- In Commercial Distribution
- Sterilization Method
- Moist Heat or Steam Sterilization
Other devices from United Orthopedic Corp.
Properties
Other properties (11)
- 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