The following data is part of a premarket notification filed by United Orthopedic Corp. with the FDA for U2 Femoral Component, Cr, Cemented.
| Device ID | K140073 |
| 510k Number | K140073 |
| Device Name: | U2 FEMORAL COMPONENT, CR, CEMENTED |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, 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 | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-13 |
| Decision Date | 2014-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719872162520 | K140073 | 000 |
| 04712602345491 | K140073 | 000 |
| 04712602345507 | K140073 | 000 |
| 04712602345514 | K140073 | 000 |
| 04712602345521 | K140073 | 000 |
| 04712602345538 | K140073 | 000 |
| 04712602345545 | K140073 | 000 |
| 04712602345552 | K140073 | 000 |
| 04712602345569 | K140073 | 000 |
| 04712602345576 | K140073 | 000 |
| 04712602345583 | K140073 | 000 |
| 04712602345590 | K140073 | 000 |
| 04712771506280 | K140073 | 000 |
| 04712771506297 | K140073 | 000 |
| 04719872162391 | K140073 | 000 |
| 04712602345484 | K140073 | 000 |