The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Titanium Intramedullary Nails-various Styles.
| Device ID | K982953 |
| 510k Number | K982953 |
| Device Name: | TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-24 |
| Decision Date | 1998-10-21 |
| Summary: | summary |