SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE

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

SYNTHES (USA)

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.

Pre-market Notification Details

Device IDK031973
510k NumberK031973
Device Name:SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactBonnie J Smith
CorrespondentBonnie J Smith
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeLXT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-26
Decision Date2003-09-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H67903390052S0 K031973 000
H6793900510 K031973 000

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