Headless Compression Screw System

Screw, Fixation, Bone

OsteoCentric Extremities, LLC

The following data is part of a premarket notification filed by Osteocentric Extremities, Llc with the FDA for Headless Compression Screw System.

Pre-market Notification Details

Device IDK200259
510k NumberK200259
Device Name:Headless Compression Screw System
ClassificationScrew, Fixation, Bone
Applicant OsteoCentric Extremities, LLC 5113 Southwest Parkway, Suite 150 Austin,  TX  78735
ContactTodd Evans
CorrespondentMeredith May
Empirical Testing Corp. 4628 Northpark Drive Colorado Springs,  CO  80918
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-03
Decision Date2020-05-04

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