The following data is part of a premarket notification filed by Howmedica Osteonics Corp., Dba Stryker Orthopaedics with the FDA for Uhr Bipolar Implants, Restoration Gap Ii Implants.
| Device ID | K222632 |
| 510k Number | K222632 |
| Device Name: | UHR Bipolar Implants, Restoration GAP II Implants |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | Howmedica Osteonics Corp., Dba Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
| Contact | Margaret Klippel |
| Correspondent | Margaret Klippel Howmedica Osteonics Corp., Dba Stryker Orthopaedics 325 Corporate Drive Mahwah, NJ 07430 |
| Product Code | KWL |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-31 |
| Decision Date | 2022-10-21 |