The following data is part of a premarket notification filed by United Orthopedic Corp. with the FDA for U2 Hip Stem, Ti Porous Coated.
| Device ID | K003237 |
| 510k Number | K003237 |
| Device Name: | U2 HIP STEM, TI POROUS COATED |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | UNITED ORTHOPEDIC CORP. 57 PARK AVE. 2, SCIENCE PARK Hsinchu, TW 300 |
| Contact | Mellen Liu |
| Correspondent | Mellen Liu UNITED ORTHOPEDIC CORP. 57 PARK AVE. 2, SCIENCE PARK Hsinchu, TW 300 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-17 |
| Decision Date | 2001-01-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872177760 | K003237 | 000 |
| 04712602340335 | K003237 | 000 |
| 04712602340342 | K003237 | 000 |
| 04712602340359 | K003237 | 000 |
| 04712602340786 | K003237 | 000 |
| 04712602340793 | K003237 | 000 |
| 04712602340809 | K003237 | 000 |
| 04712602340816 | K003237 | 000 |
| 04712602340823 | K003237 | 000 |
| 04712602340328 | K003237 | 000 |
| 04712602340311 | K003237 | 000 |
| 04712602340236 | K003237 | 000 |
| 04712602340243 | K003237 | 000 |
| 04712602340250 | K003237 | 000 |
| 04712602340267 | K003237 | 000 |
| 04712602340274 | K003237 | 000 |
| 04712602340281 | K003237 | 000 |
| 04712602340298 | K003237 | 000 |
| 04712602340304 | K003237 | 000 |
| 04712602340830 | K003237 | 000 |
| 04712602340847 | K003237 | 000 |
| 04719872156789 | K003237 | 000 |
| 04719872167020 | K003237 | 000 |
| 04719872167037 | K003237 | 000 |
| 04719872167051 | K003237 | 000 |
| 04719872167068 | K003237 | 000 |
| 04719872167082 | K003237 | 000 |
| 04719872167099 | K003237 | 000 |
| 04719872170976 | K003237 | 000 |
| 04719872177722 | K003237 | 000 |
| 04719872166993 | K003237 | 000 |
| 04719872166986 | K003237 | 000 |
| 04719872166856 | K003237 | 000 |
| 04719872166863 | K003237 | 000 |
| 04719872166870 | K003237 | 000 |
| 04719872166894 | K003237 | 000 |
| 04719872166900 | K003237 | 000 |
| 04719872166931 | K003237 | 000 |
| 04719872166955 | K003237 | 000 |
| 04719872166962 | K003237 | 000 |
| 04719872177739 | K003237 | 000 |