The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for A-b Acetabular Component.
| Device ID | K954417 |
| 510k Number | K954417 |
| Device Name: | A-B ACETABULAR COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET, INC. AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-21 |
| Decision Date | 1995-12-11 |