The following data is part of a premarket notification filed by Kinamed, Inc. with the FDA for Kinamed Ath 28mm Alumina Ceramic Long-neck Ball.
| Device ID | K912295 |
| 510k Number | K912295 |
| Device Name: | KINAMED ATH 28MM ALUMINA CERAMIC LONG-NECK BALL |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| 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 | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-22 |
| Decision Date | 1991-08-12 |