The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Lateralized Intergral Porous Primary Femoral Component.
| Device ID | K984296 |
| 510k Number | K984296 |
| Device Name: | LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Darlene Hufziger Binkley |
| Correspondent | Darlene Hufziger 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-01 |
| Decision Date | 1999-02-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304208643 | K984296 | 000 |
| 00880304208636 | K984296 | 000 |
| 00880304208629 | K984296 | 000 |
| 00880304208612 | K984296 | 000 |
| 00880304208582 | K984296 | 000 |
| 00880304208568 | K984296 | 000 |
| 00880304208551 | K984296 | 000 |
| 00880304208544 | K984296 | 000 |
| 00880304208537 | K984296 | 000 |