The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Resorbable Bone Pins.
| Device ID | K011522 |
| 510k Number | K011522 |
| Device Name: | RESORBABLE BONE PINS |
| Classification | Pin, Fixation, Smooth |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Mary L Verstynen |
| Correspondent | Mary L Verstynen BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-17 |
| Decision Date | 2001-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304564206 | K011522 | 000 |
| 00880304564190 | K011522 | 000 |