United Hip System, U2 Bipolar Implant 1503-3142
Listed
Valid until
Not applicable
FDA recalls
None ongoingDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04712771493948 | Date24 Oct 2015 | 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- Withdrawn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
- United Hip System, U2 Bipolar Implant
- Generic Name
- Bipolar femoral head outer component, hemiarthroplasty
- Model / Ref / Catalog
- 1503-3142
- Primary DI / UDI-DI
- 04712771493948
- 510(k) Number
- FDA Product Code
- KWY
- GMDN Term
- Bipolar femoral head outer component, hemiarthroplasty
- Device Class
- Class II
- Regulation Number
- 888.3390
- GUDID distribution status
- In Commercial Distribution
- Size
- Lumen/Inner Diameter — 28 MillimeterOuter Diameter — 42 Millimeter
Other devices from United Orthopedic Corp.
Properties
Other properties (8)
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No