The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for Tibial Baseplate, Tibial Insert.
| Device ID | K222700 |
| 510k Number | K222700 |
| Device Name: | Tibial Baseplate, Tibial Insert |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | United Orthopedic Corporation No 57, Park Ave 2, Science Park Hsinchu, TW 30075 |
| Contact | Lois Ho |
| Correspondent | Lois Ho United Orthopedic Corporation No 57, Park Ave 2, Science Park Hsinchu, TW 30075 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-09-07 |
| Decision Date | 2022-10-06 |