The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Biomet Calcaneal Plate.
| Device ID | K022515 |
| 510k Number | K022515 |
| Device Name: | BIOMET CALCANEAL PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46582 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46582 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-30 |
| Decision Date | 2002-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304250147 | K022515 | 000 |
| 00880304249974 | K022515 | 000 |
| 00880304249998 | K022515 | 000 |
| 00880304250000 | K022515 | 000 |
| 00880304250017 | K022515 | 000 |
| 00880304250024 | K022515 | 000 |
| 00880304250031 | K022515 | 000 |
| 00880304250048 | K022515 | 000 |
| 00880304250055 | K022515 | 000 |
| 00880304250062 | K022515 | 000 |
| 00880304250079 | K022515 | 000 |
| 00880304250086 | K022515 | 000 |
| 00880304250093 | K022515 | 000 |
| 00880304250109 | K022515 | 000 |
| 00880304250116 | K022515 | 000 |
| 00880304250123 | K022515 | 000 |
| 00880304250130 | K022515 | 000 |
| 00880304249967 | K022515 | 000 |