The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Altra Fx Hip System.
| Device ID | K063614 |
| 510k Number | K063614 |
| Device Name: | ALTRA FX HIP SYSTEM |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Becky Earl |
| Correspondent | Becky Earl BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KWA |
| Subsequent Product Code | JDI |
| Subsequent Product Code | JDL |
| Subsequent Product Code | KWL |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MAY |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-05 |
| Decision Date | 2007-02-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304520325 | K063614 | 000 |
| 00887868261091 | K063614 | 000 |
| 00887868261107 | K063614 | 000 |
| 00887868261114 | K063614 | 000 |
| 00887868261121 | K063614 | 000 |
| 00887868261138 | K063614 | 000 |
| 00880304457584 | K063614 | 000 |
| 00880304464162 | K063614 | 000 |
| 00880304467910 | K063614 | 000 |
| 00880304467927 | K063614 | 000 |
| 00880304467934 | K063614 | 000 |
| 00880304467941 | K063614 | 000 |
| 00880304520288 | K063614 | 000 |
| 00880304520295 | K063614 | 000 |
| 00880304520301 | K063614 | 000 |
| 00880304520318 | K063614 | 000 |
| 00887868261084 | K063614 | 000 |