The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Mallory-head Modular Calcar Stems With Interlocking Slots.
| Device ID | K042774 |
| 510k Number | K042774 |
| Device Name: | MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | JDL |
| Subsequent Product Code | KWA |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-05 |
| Decision Date | 2005-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00887868246630 | K042774 | 000 |
| 00887868246623 | K042774 | 000 |
| 00887868246616 | K042774 | 000 |
| 00887868246609 | K042774 | 000 |
| 00887868246593 | K042774 | 000 |
| 00887868246586 | K042774 | 000 |
| 00887868246579 | K042774 | 000 |
| 00887868246562 | K042774 | 000 |