The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Lateralized Taperloc Microplasty Femoral Components.
| Device ID | K062994 |
| 510k Number | K062994 |
| Device Name: | LATERALIZED TAPERLOC MICROPLASTY FEMORAL COMPONENTS |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KWA |
| Subsequent Product Code | JDI |
| Subsequent Product Code | JDL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MBL |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-02 |
| Decision Date | 2007-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304453692 | K062994 | 000 |
| 00880304449800 | K062994 | 000 |
| 00880304449817 | K062994 | 000 |
| 00880304452534 | K062994 | 000 |
| 00880304452541 | K062994 | 000 |
| 00880304452558 | K062994 | 000 |
| 00880304452947 | K062994 | 000 |
| 00880304453647 | K062994 | 000 |
| 00880304453654 | K062994 | 000 |
| 00880304453661 | K062994 | 000 |
| 00880304453678 | K062994 | 000 |
| 00880304453685 | K062994 | 000 |
| 00880304449794 | K062994 | 000 |