The following data is part of a premarket notification filed by Kinamed, Inc. with the FDA for Ath Ceramic Uhmwpe Total Hip System.
| Device ID | K890472 |
| 510k Number | K890472 |
| Device Name: | ATH CERAMIC UHMWPE TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | KINAMED, INC. 10780 SANTA MONICA BLVD., SUITE 100 Los Angeles, CA 90025 |
| Contact | Clarke, Phd |
| Correspondent | Clarke, Phd KINAMED, INC. 10780 SANTA MONICA BLVD., SUITE 100 Los Angeles, CA 90025 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-30 |
| Decision Date | 1989-09-01 |