The following data is part of a premarket notification filed by Kinamed, Inc. with the FDA for Kinamed 32mm Bioceram-z Toatal Hip Femoral Ball.
| Device ID | K920290 |
| 510k Number | K920290 |
| Device Name: | KINAMED 32MM BIOCERAM-Z TOATAL HIP FEMORAL BALL |
| 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 | Henry Jung |
| Correspondent | Henry Jung 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 | 1992-01-22 |
| Decision Date | 1992-11-03 |