The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Mallory-head Modular Calcar Repacement Components.
| Device ID | K945115 |
| 510k Number | K945115 |
| Device Name: | MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-18 |
| Decision Date | 1995-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304199866 | K945115 | 000 |
| 00880304055506 | K945115 | 000 |