The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Sterile Adjustable Distal Radius Fixator (adrf) With 4.0mm/3.0mm Self-drilling Schanz Screws.
| Device ID | K033411 |
| 510k Number | K033411 |
| Device Name: | SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Bonnie Smith |
| Correspondent | Bonnie Smith SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-27 |
| Decision Date | 2003-11-26 |
| Summary: | summary |