The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for Utf Stem, Reduced, #0, #00.
| Device ID | K163193 |
| 510k Number | K163193 |
| Device Name: | UTF Stem, Reduced, #0, #00 |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | UNITED ORTHOPEDIC CORPORATION NO 57, PARK AVE 2, SCIENCE PARK Hsinchu, TW 300 |
| Contact | Gimpel Chien |
| Correspondent | Gimpel Chien UNITED ORTHOPEDIC CORPORATION NO 57, PARK AVE 2, SCIENCE PARK Hsinchu, TW 300 |
| Product Code | LPH |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-15 |
| Decision Date | 2017-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872177814 | K163193 | 000 |
| 04719886900507 | K163193 | 000 |
| 04711605585033 | K163193 | 000 |
| 04711605585088 | K163193 | 000 |
| 04711605585149 | K163193 | 000 |
| 04711605585156 | K163193 | 000 |
| 04712771504941 | K163193 | 000 |
| 04712771505078 | K163193 | 000 |
| 04712771505207 | K163193 | 000 |
| 04719872167396 | K163193 | 000 |
| 04719872167587 | K163193 | 000 |
| 04719872167594 | K163193 | 000 |
| 04719872171188 | K163193 | 000 |
| 04719872171232 | K163193 | 000 |
| 04719886900453 | K163193 | 000 |