The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for U2 Femoral Component, Cr, Porous Coated, Additional Sizes.
| Device ID | K150832 |
| 510k Number | K150832 |
| Device Name: | U2 Femoral Component, CR, Porous Coated, Additional Sizes |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| 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 | MBH |
| CFR Regulation Number | 888.3565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-30 |
| Decision Date | 2015-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872166634 | K150832 | 000 |
| 04711605574334 | K150832 | 000 |
| 04711605574341 | K150832 | 000 |
| 04711605574358 | K150832 | 000 |
| 04711605574365 | K150832 | 000 |
| 04711605574372 | K150832 | 000 |
| 04711605574389 | K150832 | 000 |
| 04711605574396 | K150832 | 000 |
| 04711605574402 | K150832 | 000 |
| 04711605574419 | K150832 | 000 |
| 04711605574426 | K150832 | 000 |
| 04711605574433 | K150832 | 000 |
| 04719872166405 | K150832 | 000 |
| 04719872166412 | K150832 | 000 |
| 04719872166627 | K150832 | 000 |
| 04711605574327 | K150832 | 000 |