The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Biosymmetric Proximal Interphalangeal Joint Fixator.
| Device ID | K980370 |
| 510k Number | K980370 |
| Device Name: | BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Patricia S Beres |
| Correspondent | Patricia S Beres BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-30 |
| Decision Date | 1998-04-14 |
| Summary: | summary |