SYNTHES STERNAL FIXATION SYSTEM

Plate, Fixation, Bone

SYNTHES

The following data is part of a premarket notification filed by Synthes with the FDA for Synthes Sternal Fixation System.

Pre-market Notification Details

Device IDK093772
510k NumberK093772
Device Name:SYNTHES STERNAL FIXATION SYSTEM
ClassificationPlate, Fixation, Bone
Applicant SYNTHES 1301 Goshen Parkway West Chester,  PA  19380
ContactAndrea M Tasker
CorrespondentAndrea M Tasker
SYNTHES 1301 Goshen Parkway West Chester,  PA  19380
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-08
Decision Date2010-03-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H980460172S0 K093772 000
H980460171S0 K093772 000

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