The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Taper 2 Porous Femoral Stem.
| Device ID | K050441 |
| 510k Number | K050441 |
| Device Name: | TAPER 2 POROUS FEMORAL STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Kacy Arnold |
| Correspondent | Kacy Arnold BIOMET, INC. 56 EAST BELL DR. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDI |
| Subsequent Product Code | JDL |
| Subsequent Product Code | KWA |
| Subsequent Product Code | KWB |
| Subsequent Product Code | KWY |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LZO |
| Subsequent Product Code | LZY |
| Subsequent Product Code | MBL |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-22 |
| Decision Date | 2005-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304592803 | K050441 | 000 |
| 00880304438415 | K050441 | 000 |
| 00880304438422 | K050441 | 000 |
| 00880304438439 | K050441 | 000 |
| 00880304438446 | K050441 | 000 |
| 00880304438453 | K050441 | 000 |
| 00880304438460 | K050441 | 000 |
| 00880304438477 | K050441 | 000 |
| 00880304438484 | K050441 | 000 |
| 00880304438491 | K050441 | 000 |
| 00880304438507 | K050441 | 000 |
| 00880304438514 | K050441 | 000 |
| 00880304438521 | K050441 | 000 |
| 00880304591745 | K050441 | 000 |
| 00880304591752 | K050441 | 000 |
| 00880304592797 | K050441 | 000 |
| 00880304438408 | K050441 | 000 |