The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Titanium Pediatric Femoral Nail.
| Device ID | K993956 |
| 510k Number | K993956 |
| Device Name: | TITANIUM PEDIATRIC FEMORAL NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Lonnie Witham |
| Correspondent | Lonnie Witham BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-22 |
| Decision Date | 1999-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304510456 | K993956 | 000 |
| 00888480232391 | K993956 | 000 |
| 00880304487017 | K993956 | 000 |
| 00880304500501 | K993956 | 000 |
| 00880304505858 | K993956 | 000 |
| 00880304506336 | K993956 | 000 |
| 00880304506350 | K993956 | 000 |
| 00880304507364 | K993956 | 000 |
| 00880304507500 | K993956 | 000 |
| 00880304507739 | K993956 | 000 |
| 00880304507746 | K993956 | 000 |
| 00880304508347 | K993956 | 000 |
| 00880304508415 | K993956 | 000 |
| 00880304508422 | K993956 | 000 |
| 00880304508439 | K993956 | 000 |
| 00880304509238 | K993956 | 000 |
| 00888480231134 | K993956 | 000 |