The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Xr-series Bi-metric Femoral Components.
| Device ID | K052089 |
| 510k Number | K052089 |
| Device Name: | XR-SERIES BI-METRIC FEMORAL COMPONENTS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | BIOMET MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn-beres |
| Correspondent | Patricia Sandborn-beres BIOMET MANUFACTURING, INC. AIRPORT INDUSTRIAL PARK P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-02 |
| Decision Date | 2006-02-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304650718 | K052089 | 000 |
| 00880304650510 | K052089 | 000 |
| 00880304650350 | K052089 | 000 |
| 00880304650343 | K052089 | 000 |
| 00880304650336 | K052089 | 000 |
| 00880304650329 | K052089 | 000 |
| 00880304650312 | K052089 | 000 |
| 00880304650305 | K052089 | 000 |
| 00880304650299 | K052089 | 000 |
| 00880304650282 | K052089 | 000 |
| 00880304461079 | K052089 | 000 |
| 00880304650770 | K052089 | 000 |
| 00880304650763 | K052089 | 000 |
| 00880304650749 | K052089 | 000 |
| 00880304650732 | K052089 | 000 |
| 00880304650725 | K052089 | 000 |
| 00880304650527 | K052089 | 000 |
| 00880304650534 | K052089 | 000 |
| 00880304650701 | K052089 | 000 |
| 00880304650695 | K052089 | 000 |
| 00880304650688 | K052089 | 000 |
| 00880304650671 | K052089 | 000 |
| 00880304650664 | K052089 | 000 |
| 00880304650657 | K052089 | 000 |
| 00880304650633 | K052089 | 000 |
| 00880304650626 | K052089 | 000 |
| 00880304650619 | K052089 | 000 |
| 00880304650602 | K052089 | 000 |
| 00880304650596 | K052089 | 000 |
| 00880304650589 | K052089 | 000 |
| 00880304650572 | K052089 | 000 |
| 00880304650565 | K052089 | 000 |
| 00880304650558 | K052089 | 000 |
| 00880304496798 | K052089 | 000 |