The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for United U2 Femoral Head, 22mm Delta Ceramic Head.
| Device ID | K221675 |
| 510k Number | K221675 |
| Device Name: | United U2 Femoral Head, 22mm Delta Ceramic Head |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | United Orthopedic Corporation No 57, Park Ave 2, Science Park Hsinchu, TW 30075 |
| Contact | Lois Ho |
| Correspondent | Lois Ho United Orthopedic Corporation No.57 Park Ave. 2, Science Park Hsinchu City, TW |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-09 |
| Decision Date | 2022-11-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719886890846 | K221675 | 000 |
| 04719886890839 | K221675 | 000 |
| 04719886890822 | K221675 | 000 |