SYNTHES RAPID RESORBABLE TACK SYSTEM

Plate, Bone

SYNTHES (USA)

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

Pre-market Notification Details

Device IDK050204
510k NumberK050204
Device Name:SYNTHES RAPID RESORBABLE TACK SYSTEM
ClassificationPlate, Bone
Applicant SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
SYNTHES (USA) 1690 RUSSELL RD. Paoli,  PA  19301
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-28
Decision Date2005-03-04
Summary:summary

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