The following data is part of a premarket notification filed by Bonutti Research, Inc. with the FDA for Transet Fracture Fixation System.
| Device ID | K033717 |
| 510k Number | K033717 |
| Device Name: | TRANSET FRACTURE FIXATION SYSTEM |
| Classification | Pin, Fixation, Smooth |
| Applicant | BONUTTI RESEARCH, INC. 2600 SOUTH RANEY P.O. BOX 1367 Effingham, IL 62401 |
| Contact | Patrick G Balsmann |
| Correspondent | Patrick G Balsmann BONUTTI RESEARCH, INC. 2600 SOUTH RANEY P.O. BOX 1367 Effingham, IL 62401 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-26 |
| Decision Date | 2004-02-25 |
| Summary: | summary |