The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Mallory/head Lateralized Press-fit Femoral.
| Device ID | K000538 |
| 510k Number | K000538 |
| Device Name: | MALLORY/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 | 2000-02-17 |
| Decision Date | 2000-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304199477 | K000538 | 000 |
| 00887868264412 | K000538 | 000 |
| 00887868264429 | K000538 | 000 |
| 00887868264436 | K000538 | 000 |
| 00887868264443 | K000538 | 000 |
| 00887868264450 | K000538 | 000 |
| 00887868307843 | K000538 | 000 |
| 00887868307850 | K000538 | 000 |
| 00887868307867 | K000538 | 000 |
| 00887868307874 | K000538 | 000 |
| 00887868307881 | K000538 | 000 |
| 00887868307898 | K000538 | 000 |
| 00880304000728 | K000538 | 000 |
| 00880304005891 | K000538 | 000 |
| 00880304009578 | K000538 | 000 |
| 00880304010222 | K000538 | 000 |
| 00880304010253 | K000538 | 000 |
| 00887868264405 | K000538 | 000 |