The following data is part of a premarket notification filed by Kinamed, Inc. with the FDA for Ath Full Profile Acetabular Cup System.
| Device ID | K954213 |
| 510k Number | K954213 |
| Device Name: | ATH FULL PROFILE ACETABULAR CUP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | KINAMED, INC. 9229 CRANFORD DR. Potomac, MD 20854 |
| Contact | Joel Slomoff |
| Correspondent | Joel Slomoff KINAMED, INC. 9229 CRANFORD DR. Potomac, MD 20854 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-07 |
| Decision Date | 1995-10-25 |