The following data is part of a premarket notification filed by Kinamed, Inc. with the FDA for Kinamed Ath 22mm Cocr Total Hlip Femoral Head.
| Device ID | K903885 |
| 510k Number | K903885 |
| Device Name: | KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEAD |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal |
| Applicant | KINAMED, INC. 2000 M ST. N.W SUITE 700 Washington, DC 20036 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli KINAMED, INC. 2000 M ST. N.W SUITE 700 Washington, DC 20036 |
| Product Code | KWL |
| CFR Regulation Number | 888.3360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-21 |
| Decision Date | 1990-09-13 |