SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Combination Clamp And Dynamization Clip.

Pre-market Notification Details

Device IDK973017
510k NumberK973017
Device Name:SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli,  PA  19301
ContactKevin J O'connell
CorrespondentKevin J O'connell
SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli,  PA  19301
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-13
Decision Date1997-10-16
Summary:summary

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