REDUCT® Headless Compression Screw System

Screw, Fixation, Bone

Skeletal Dynamics, Inc.

The following data is part of a premarket notification filed by Skeletal Dynamics, Inc. with the FDA for Reduct® Headless Compression Screw System.

Pre-market Notification Details

Device IDK201662
510k NumberK201662
Device Name:REDUCT® Headless Compression Screw System
ClassificationScrew, Fixation, Bone
Applicant Skeletal Dynamics, Inc. 7300 N. Kendall Drive, Suite 400 Miami,  FL  33156
ContactDiana Taylor
CorrespondentDiana Taylor
Skeletal Dynamics, Inc. 7300 N. Kendall Drive, Suite 400 Miami,  FL  33156
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-19
Decision Date2020-07-16

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.