The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for Utf Stem-reduced, Additional Sizes.
| Device ID | K132207 |
| 510k Number | K132207 |
| Device Name: | UTF STEM-REDUCED, ADDITIONAL SIZES |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | UNITED ORTHOPEDIC CORPORATION NO 57, PARK AVE 2, SCIENCE PARK Hsinchu, TW 300 |
| Contact | Fang-yuan Ho |
| Correspondent | Fang-yuan Ho 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-16 |
| Decision Date | 2013-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872171270 | K132207 | 000 |
| 04711605585330 | K132207 | 000 |
| 04711605585323 | K132207 | 000 |
| 04711605585293 | K132207 | 000 |
| 04711605585286 | K132207 | 000 |
| 04711605585279 | K132207 | 000 |
| 04711605585125 | K132207 | 000 |
| 04711605585071 | K132207 | 000 |
| 04719886900545 | K132207 | 000 |
| 04711605567480 | K132207 | 000 |
| 04711605567497 | K132207 | 000 |
| 04711605567503 | K132207 | 000 |
| 04719872171225 | K132207 | 000 |
| 04719872167570 | K132207 | 000 |
| 04719872167563 | K132207 | 000 |
| 04719872157021 | K132207 | 000 |
| 04719872157007 | K132207 | 000 |
| 04712771505191 | K132207 | 000 |
| 04712771505054 | K132207 | 000 |
| 04711605567510 | K132207 | 000 |
| 04719886900491 | K132207 | 000 |