The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Pediatric Fixation Rods.
| Device ID | K000764 |
| 510k Number | K000764 |
| Device Name: | PEDIATRIC FIXATION RODS |
| Classification | Nail, Fixation, Bone |
| Applicant | BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Contact | Patricia Sandborn Beres |
| Correspondent | Patricia Sandborn Beres BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Product Code | JDS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-09 |
| Decision Date | 2000-04-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304492714 | K000764 | 000 |
| 00880304487260 | K000764 | 000 |
| 00880304285736 | K000764 | 000 |
| 00880304285729 | K000764 | 000 |
| 00880304487277 | K000764 | 000 |