Distal Humerus Plating System

Plate, Fixation, Bone

Skeletal Dynamics, Inc.

The following data is part of a premarket notification filed by Skeletal Dynamics, Inc. with the FDA for Distal Humerus Plating System.

Pre-market Notification Details

Device IDK200367
510k NumberK200367
Device Name:Distal Humerus Plating System
ClassificationPlate, Fixation, Bone
Applicant Skeletal Dynamics, Inc. 7300 N. Kendall Drive, Suite 400 Miami,  FL  33156
ContactAna M. Escagedo
CorrespondentAna M. Escagedo
Skeletal Dynamics, Inc. 7300 N. Kendall Drive, Suite 400 Miami,  FL  33156
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-14
Decision Date2020-05-14

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