Tyber Medical Anatomical Plating System

Plate, 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 Anatomical Plating System.

Pre-market Notification Details

Device IDK193222
510k NumberK193222
Device Name:Tyber Medical Anatomical Plating System
ClassificationPlate, Fixation, Bone
Applicant Tyber Medical LLC 83 South Commerce Way, Suite 310 Bethlehem,  PA  18017
ContactMark Schenk
CorrespondentJessica Stigliano
Tyber Medical LLC 83 South Commerce Way, Suite 310 Bethlehem,  PA  18017
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-22
Decision Date2020-01-20

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