SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 3.5mm Quadrilateral Surface Plates.

Pre-market Notification Details

Device IDK093928
510k NumberK093928
Device Name:SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES
ClassificationPlate, Fixation, Bone
Applicant SYNTHES (USA) 1301 GOSHEN PKWY. West Chester,  PA  19380
ContactKarl J Nittinger
CorrespondentKarl J Nittinger
SYNTHES (USA) 1301 GOSHEN PKWY. West Chester,  PA  19380
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-22
Decision Date2010-03-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
H67902100327S0 K093928 000
H67902100326S0 K093928 000
H67902100325S0 K093928 000

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