The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for Ucp Stem.
| Device ID | K152530 |
| 510k Number | K152530 |
| Device Name: | UCP Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-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 | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LWJ |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-03 |
| Decision Date | 2016-03-14 |
| Summary: | summary |