The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for U2 Hip Stem, Ti Porous Coated, Matrix.
| Device ID | K151316 |
| 510k Number | K151316 |
| Device Name: | U2 Hip Stem, Ti Porous Coated, Matrix |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | United Orthopedic Corporation No 57, Park Ave 2, Science Park Hsinchu, TW 300 |
| Contact | Karen Ho |
| Correspondent | Karen Ho United Orthopedic Corporation No 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 | 2015-05-18 |
| Decision Date | 2015-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872172413 | K151316 | 000 |
| 04712771495768 | K151316 | 000 |
| 04712771495775 | K151316 | 000 |
| 04712771495782 | K151316 | 000 |
| 04712771495799 | K151316 | 000 |
| 04712771495805 | K151316 | 000 |
| 04712771495812 | K151316 | 000 |
| 04712771495829 | K151316 | 000 |
| 04712771495836 | K151316 | 000 |
| 04712771495843 | K151316 | 000 |
| 04712771495850 | K151316 | 000 |
| 04712771495867 | K151316 | 000 |
| 04712771495874 | K151316 | 000 |
| 04719872172406 | K151316 | 000 |
| 04712771495751 | K151316 | 000 |