The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Compress Segmental Femoral Replacement System (short Spindle And Anchor Plug).
| Device ID | K062998 |
| 510k Number | K062998 |
| Device Name: | COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM (SHORT SPINDLE AND ANCHOR PLUG) |
| Classification | Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Applicant | BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Jing Xie |
| Correspondent | Jing Xie BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KWA |
| Subsequent Product Code | JDI |
| Subsequent Product Code | JDL |
| Subsequent Product Code | KRO |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-02 |
| Decision Date | 2007-01-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304652866 | K062998 | 000 |
| 00880304461765 | K062998 | 000 |
| 00880304461758 | K062998 | 000 |
| 00880304461741 | K062998 | 000 |
| 00880304461734 | K062998 | 000 |
| 00880304461727 | K062998 | 000 |
| 00880304461710 | K062998 | 000 |
| 00880304461703 | K062998 | 000 |
| 00880304461697 | K062998 | 000 |
| 00880304461680 | K062998 | 000 |
| 00880304461673 | K062998 | 000 |
| 00880304461666 | K062998 | 000 |
| 00880304461659 | K062998 | 000 |
| 00880304461642 | K062998 | 000 |
| 00880304461635 | K062998 | 000 |
| 00880304461628 | K062998 | 000 |
| 00880304461611 | K062998 | 000 |
| 00880304461604 | K062998 | 000 |
| 00880304461772 | K062998 | 000 |
| 00880304461789 | K062998 | 000 |
| 00880304554825 | K062998 | 000 |
| 00880304528697 | K062998 | 000 |
| 00880304528352 | K062998 | 000 |
| 00880304525740 | K062998 | 000 |
| 00880304525733 | K062998 | 000 |
| 00880304523951 | K062998 | 000 |
| 00880304479289 | K062998 | 000 |
| 00880304479272 | K062998 | 000 |
| 00880304469303 | K062998 | 000 |
| 00880304468412 | K062998 | 000 |
| 00880304468405 | K062998 | 000 |
| 00880304468399 | K062998 | 000 |
| 00880304468382 | K062998 | 000 |
| 00880304468375 | K062998 | 000 |
| 00880304468368 | K062998 | 000 |
| 00880304468351 | K062998 | 000 |
| 00880304468344 | K062998 | 000 |
| 00880304454378 | K062998 | 000 |