Small Bone Nailing System

Pin, Fixation, Smooth

Skeletal Dynamics, Inc.

The following data is part of a premarket notification filed by Skeletal Dynamics, Inc. with the FDA for Small Bone Nailing System.

Pre-market Notification Details

Device IDK211439
510k NumberK211439
Device Name:Small Bone Nailing System
ClassificationPin, Fixation, Smooth
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 CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-10
Decision Date2021-09-30

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