SYNTHES 3.0 MM PC-FIX SYSTEM

Screw, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 3.0 Mm Pc-fix System.

Pre-market Notification Details

Device IDK981372
510k NumberK981372
Device Name:SYNTHES 3.0 MM PC-FIX SYSTEM
ClassificationScrew, Fixation, Bone
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 CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-16
Decision Date1998-05-11
Summary:summary

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