SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES

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 Reprocessed External Fixation Devices.

Pre-market Notification Details

Device IDK033158
510k NumberK033158
Device Name:SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactAnglela J Silvestri
CorrespondentAnglela J Silvestri
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-30
Decision Date2003-11-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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