SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM

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 Small Fragment Dynamic Compression Locking (dcl) System.

Pre-market Notification Details

Device IDK000684
510k NumberK000684
Device Name:SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactAngela J Silvestri
CorrespondentAngela J Silvestri
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-29
Decision Date2000-04-28
Summary:summary

NIH GUDID Devices

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