The following data is part of a premarket notification filed by Kinamed, Inc. with the FDA for Acetabular Shells & Liners For Ath Total Hip Syst..
| Device ID | K893821 |
| 510k Number | K893821 |
| Device Name: | ACETABULAR SHELLS & LINERS FOR ATH TOTAL HIP SYST. |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| 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 | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-23 |
| Decision Date | 1989-11-06 |