The following data is part of a premarket notification filed by United Orthopedic Corp. with the FDA for U2 Femoral Component, Cr, Porous Coated.
| Device ID | K140075 |
| 510k Number | K140075 |
| Device Name: | U2 FEMORAL COMPONENT, CR, POROUS COATED |
| Classification | Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | UNITED ORTHOPEDIC CORP. NO. 57, PARK AVE 2, SCIENCE PARK Hsinchu, TW 300 |
| Contact | Fang-yuan Ho |
| Correspondent | Fang-yuan Ho UNITED ORTHOPEDIC CORP. 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 | 2014-01-13 |
| Decision Date | 2014-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872178026 | K140075 | 000 |
| 04712602345453 | K140075 | 000 |
| 04712602345446 | K140075 | 000 |
| 04712602345439 | K140075 | 000 |
| 04712602345422 | K140075 | 000 |
| 04712602345415 | K140075 | 000 |
| 04712602345408 | K140075 | 000 |
| 04712602345392 | K140075 | 000 |
| 04712602345385 | K140075 | 000 |
| 04712602345378 | K140075 | 000 |
| 04712602345460 | K140075 | 000 |
| 04712602345477 | K140075 | 000 |
| 04719872178019 | K140075 | 000 |
| 04719872177982 | K140075 | 000 |
| 04719872177975 | K140075 | 000 |
| 04719872177968 | K140075 | 000 |
| 04719872177951 | K140075 | 000 |
| 04719872177944 | K140075 | 000 |
| 04719872175353 | K140075 | 000 |
| 04712771506273 | K140075 | 000 |
| 04712771506266 | K140075 | 000 |
| 04712602345361 | K140075 | 000 |