The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Ha Mallory/head Porous Femoral Stem & Ha Mallory/head Porous Lateralized Femoral Stem.
| Device ID | K021403 |
| 510k Number | K021403 |
| Device Name: | HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD 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 | 2002-05-02 |
| Decision Date | 2002-05-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304282377 | K021403 | 000 |
| 00880304281738 | K021403 | 000 |
| 00880304281721 | K021403 | 000 |
| 00880304281714 | K021403 | 000 |
| 00887868311154 | K021403 | 000 |
| 00887868311147 | K021403 | 000 |
| 00887868311130 | K021403 | 000 |
| 00887868311123 | K021403 | 000 |
| 00887868311116 | K021403 | 000 |
| 00887868311109 | K021403 | 000 |
| 00887868311093 | K021403 | 000 |
| 00887868311086 | K021403 | 000 |
| 00887868311079 | K021403 | 000 |
| 00887868311062 | K021403 | 000 |
| 00880304281745 | K021403 | 000 |
| 00880304281752 | K021403 | 000 |
| 00880304281769 | K021403 | 000 |
| 00880304282360 | K021403 | 000 |
| 00880304282353 | K021403 | 000 |
| 00880304282346 | K021403 | 000 |
| 00880304282339 | K021403 | 000 |
| 00880304282322 | K021403 | 000 |
| 00880304282315 | K021403 | 000 |
| 00880304282308 | K021403 | 000 |
| 00880304282292 | K021403 | 000 |
| 00880304281813 | K021403 | 000 |
| 00880304281806 | K021403 | 000 |
| 00880304281790 | K021403 | 000 |
| 00880304281783 | K021403 | 000 |
| 00880304281776 | K021403 | 000 |
| 00887868311055 | K021403 | 000 |