The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Generation 4 Polished Femoral Hip Prosthesis With Proximal Cement Spacer.
| Device ID | K052639 |
| 510k Number | K052639 |
| Device Name: | GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Susan Alexander |
| Correspondent | Susan Alexander BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Product Code | JDI |
| Subsequent Product Code | JDG |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-26 |
| Decision Date | 2006-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304591332 | K052639 | 000 |
| 00880304497405 | K052639 | 000 |
| 00880304521858 | K052639 | 000 |
| 00880304554757 | K052639 | 000 |
| 00880304554764 | K052639 | 000 |
| 00880304591295 | K052639 | 000 |
| 00880304591301 | K052639 | 000 |
| 00880304591318 | K052639 | 000 |
| 00880304591325 | K052639 | 000 |
| 00880304457577 | K052639 | 000 |