The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for Conformity Stem, Cemented.
| Device ID | K191056 |
| 510k Number | K191056 |
| Device Name: | Conformity Stem, Cemented |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | United Orthopedic Corporation No 57, Park Ave 2, Science Park Hsinchu City, TW 30075 |
| Contact | Lois Ho |
| Correspondent | Lois Ho United Orthopedic Corporation No 57, Park Ave 2, Science Park Hsinchu City, TW 30075 |
| Product Code | JDI |
| Subsequent Product Code | KWY |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-19 |
| Decision Date | 2020-01-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04711605583565 | K191056 | 000 |
| 04711605583657 | K191056 | 000 |
| 04711605583640 | K191056 | 000 |
| 04711605583633 | K191056 | 000 |
| 04711605583626 | K191056 | 000 |
| 04711605583619 | K191056 | 000 |
| 04711605583602 | K191056 | 000 |
| 04711605583596 | K191056 | 000 |
| 04711605583589 | K191056 | 000 |
| 04711605583664 | K191056 | 000 |
| 04711605583671 | K191056 | 000 |
| 04711605583756 | K191056 | 000 |
| 04711605583749 | K191056 | 000 |
| 04711605583732 | K191056 | 000 |
| 04711605583725 | K191056 | 000 |
| 04711605583718 | K191056 | 000 |
| 04711605583701 | K191056 | 000 |
| 04711605583695 | K191056 | 000 |
| 04711605583688 | K191056 | 000 |
| 04711605583572 | K191056 | 000 |