The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Generation 4 Polished Femoral Hip Prosthesis.
| Device ID | K031734 |
| 510k Number | K031734 |
| Device Name: | GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Gary Baker |
| Correspondent | Gary Baker BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-04 |
| Decision Date | 2003-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304253599 | K031734 | 000 |
| 00880304253582 | K031734 | 000 |
| 00880304253568 | K031734 | 000 |
| 00880304253544 | K031734 | 000 |
| 00880304253537 | K031734 | 000 |