The following data is part of a premarket notification filed by Kinamed, Inc. with the FDA for Kinamed Ath-ha & Ath-ha Long Total Hip.
| Device ID | K914843 |
| 510k Number | K914843 |
| Device Name: | KINAMED ATH-HA & ATH-HA LONG TOTAL HIP |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| 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 | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-28 |
| Decision Date | 1992-02-03 |