Tyber Medical Trauma Screws

Screw, Fixation, Bone

Tyber Medical LLC

The following data is part of a premarket notification filed by Tyber Medical Llc with the FDA for Tyber Medical Trauma Screws.

Pre-market Notification Details

Device IDK192975
510k NumberK192975
Device Name:Tyber Medical Trauma Screws
ClassificationScrew, Fixation, Bone
Applicant Tyber Medical LLC 83 South Commerce Way Bethlehem,  PA  18017
ContactMark Schenk
CorrespondentJessica Stigliano
Tyber Medical LLC 83 South Commerce Way Bethlehem,  PA  18017
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-24
Decision Date2020-01-09

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