The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Resorbable Hammertoe Pin.
| Device ID | K011137 |
| 510k Number | K011137 |
| Device Name: | RESORBABLE HAMMERTOE PIN |
| Classification | Pin, Fixation, Threaded |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Sara A Bailey |
| Correspondent | Sara A Bailey BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JDW |
| Subsequent Product Code | HTY |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-13 |
| Decision Date | 2001-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304423657 | K011137 | 000 |
| 00880304423640 | K011137 | 000 |
| 00880304418721 | K011137 | 000 |
| 00880304418714 | K011137 | 000 |