The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Malloy/head Lateralized Press-fit Femoral.
| Device ID | K003429 |
| 510k Number | K003429 |
| Device Name: | MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Dalene T Binkley |
| Correspondent | Dalene T Binkley BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-03 |
| Decision Date | 2000-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304010345 | K003429 | 000 |
| 00887868264467 | K003429 | 000 |
| 00887868264474 | K003429 | 000 |
| 00887868264481 | K003429 | 000 |
| 00887868307836 | K003429 | 000 |
| 00887868307904 | K003429 | 000 |
| 00887868307911 | K003429 | 000 |
| 00887868307928 | K003429 | 000 |
| 00880304001336 | K003429 | 000 |
| 00880304010284 | K003429 | 000 |
| 00880304010338 | K003429 | 000 |
| 00887868264399 | K003429 | 000 |