SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES

Plate, Fixation, Bone

SYNTHES (USA)

The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 3.5mm Lcp Periarticular Proximal Humerus Plates.

Pre-market Notification Details

Device IDK082625
510k NumberK082625
Device Name:SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS 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 Received2008-09-09
Decision Date2008-12-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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H67902123027S0 K082625 000
H67902123043S0 K082625 000

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