The following data is part of a premarket notification filed by Kinamed, Inc. with the FDA for Ath Metal:uhmwpe Total Hip System.
| Device ID | K882675 |
| 510k Number | K882675 |
| Device Name: | ATH METAL:UHMWPE TOTAL HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | KINAMED, INC. 10780 SANTA MONICA BLVD., SUITE 100 Los Angeles, CA 90025 |
| Contact | Oette |
| Correspondent | Oette KINAMED, INC. 10780 SANTA MONICA BLVD., SUITE 100 Los Angeles, CA 90025 |
| Product Code | KWA |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-28 |
| Decision Date | 1988-08-19 |