Screw, Fixation, Bone

Retrofix Screws, LLC

The following data is part of a premarket notification filed by Retrofix Screws, Llc with the FDA for Retrofix.

Pre-market Notification Details

Device IDK200226
510k NumberK200226
Device Name:RetroFix
ClassificationScrew, Fixation, Bone
Applicant Retrofix Screws, LLC 1035 Lincolnton Road Salisbury,  NC  28144
ContactKeith A Barritt
CorrespondentKeith A Barritt
Fish & Richardson P.C. 1000 Maine Avenue, S.W. Suite 1000 Washington,  DC  20024
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-30
Decision Date2020-06-26

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