Tyber Medical Wedge System

Bone Wedge

Tyber Medical LLC

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

Pre-market Notification Details

Device IDK171327
510k NumberK171327
Device Name:Tyber Medical Wedge System
ClassificationBone Wedge
Applicant Tyber Medical LLC 83 S Commerce Way, Suite 310 Bethlehem,  PA  18017
ContactMark F. Schenk
CorrespondentMark F. Schenk
Tyber Medical LLC 83 S Commerce Way, Suite 310 Bethlehem,  PA  18017
Product CodePLF  
Subsequent Product CodeHRS
Subsequent Product CodeHWC
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-05
Decision Date2017-05-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M69535000001210 K171327 000

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