The following data is part of a premarket notification filed by Kinamed, Inc. with the FDA for Kinamed Reality Total Hip System.
| Device ID | K922247 |
| 510k Number | K922247 |
| Device Name: | KINAMED REALITY TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | KINAMED, INC. 2192-C ANCHOR COURT Newbury Park, CA 91320 |
| Contact | Ian C Clarke |
| Correspondent | Ian C Clarke KINAMED, INC. 2192-C ANCHOR COURT Newbury Park, CA 91320 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-13 |
| Decision Date | 1994-03-30 |