SYNTHES CRANIAL SPRING CLIP (CSC)

Plate, Cranioplasty, Preformed, Alterable

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Cranial Spring Clip (csc).

Pre-market Notification Details

Device IDK974206
510k NumberK974206
Device Name:SYNTHES CRANIAL SPRING CLIP (CSC)
ClassificationPlate, Cranioplasty, Preformed, Alterable
Applicant SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
ContactSheri Musgnung
CorrespondentSheri Musgnung
SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli,  PA  19301 -1222
Product CodeGWO  
CFR Regulation Number882.5320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-11-10
Decision Date1998-03-16
Summary:summary

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