The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Taperloc Porous Femoral Stem & Ha Taperloc Porous Lateralized Femoral Stem.
| Device ID | K020963 |
| 510k Number | K020963 |
| Device Name: | TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| Applicant | BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Dalene T Binkley |
| Correspondent | Dalene T Binkley BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-25 |
| Decision Date | 2002-04-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304282285 | K020963 | 000 |
| 00880304281691 | K020963 | 000 |
| 00880304281684 | K020963 | 000 |
| 00880304281677 | K020963 | 000 |
| 00880304281653 | K020963 | 000 |
| 00880304281646 | K020963 | 000 |
| 00880304281639 | K020963 | 000 |
| 00880304281622 | K020963 | 000 |
| 00880304281615 | K020963 | 000 |
| 00880304281608 | K020963 | 000 |
| 00880304281707 | K020963 | 000 |
| 00880304282186 | K020963 | 000 |
| 00880304282278 | K020963 | 000 |
| 00880304282261 | K020963 | 000 |
| 00880304282254 | K020963 | 000 |
| 00880304282247 | K020963 | 000 |
| 00880304282230 | K020963 | 000 |
| 00880304282223 | K020963 | 000 |
| 00880304282216 | K020963 | 000 |
| 00880304282209 | K020963 | 000 |
| 00880304282193 | K020963 | 000 |
| 00880304281592 | K020963 | 000 |