SYNTHES CERVIFIX SYSTEM

Appliance, Fixation, Spinal Interlaminal

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Cervifix System.

Pre-market Notification Details

Device IDK994187
510k NumberK994187
Device Name:SYNTHES CERVIFIX SYSTEM
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant SYNTHES (USA) P.O. BOX 0548 1690 RUSSELL ROAD Paoli,  PA  19301
ContactJonathan Gilbert
CorrespondentJonathan Gilbert
SYNTHES (USA) P.O. BOX 0548 1690 RUSSELL ROAD Paoli,  PA  19301
Product CodeKWP  
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-13
Decision Date1999-12-21
Summary:summary

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