The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 4.0 Mm Adjustable Clamp For Distal Radius Fixator-mr Safe.
Device ID | K031973 |
510k Number | K031973 |
Device Name: | SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE |
Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Contact | Bonnie J Smith |
Correspondent | Bonnie J Smith SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
Product Code | LXT |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-06-26 |
Decision Date | 2003-09-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
H67903390052S0 | K031973 | 000 |
H6793900510 | K031973 | 000 |