EVOS Straight Proximal Humerus 7-15 Hole Plates (137-225mm)

Plate, Fixation, Bone

Smith & Nephew, Inc.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Evos Straight Proximal Humerus 7-15 Hole Plates (137-225mm).

Pre-market Notification Details

Device IDK201527
510k NumberK201527
Device Name:EVOS Straight Proximal Humerus 7-15 Hole Plates (137-225mm)
ClassificationPlate, Fixation, Bone
Applicant Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova,  TN  38016
ContactKayla Franklin
CorrespondentKayla Franklin
Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova,  TN  38016
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-08
Decision Date2020-07-22

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