The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for 2mm Pediatric Flex Nail.
| Device ID | K022531 |
| 510k Number | K022531 |
| Device Name: | 2MM PEDIATRIC FLEX NAIL |
| Classification | Pin, Fixation, Smooth |
| Applicant | BIOMET, INC. 56 BELL DR. PO BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Tracy J Bickel |
| Correspondent | Tracy J Bickel BIOMET, INC. 56 BELL DR. PO BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-31 |
| Decision Date | 2002-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304487277 | K022531 | 000 |
| 00880304285712 | K022531 | 000 |