SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM

Plate, Bone

SYNTHES (USA)

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

Pre-market Notification Details

Device IDK062789
510k NumberK062789
Device Name:SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
ClassificationPlate, Bone
Applicant SYNTHES (USA) 1230 WILSON DRIVE West Chester,  PA  19380
ContactJeffrey Dow
CorrespondentJeffrey Dow
SYNTHES (USA) 1230 WILSON DRIVE West Chester,  PA  19380
Product CodeJEY  
CFR Regulation Number872.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-18
Decision Date2007-02-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H98085163501S0 K062789 000

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