Tyber Medical PT Interbody Spacer

Intervertebral Fusion Device With Bone Graft, Cervical

Tyber Medical LLC

The following data is part of a premarket notification filed by Tyber Medical Llc with the FDA for Tyber Medical Pt Interbody Spacer.

Pre-market Notification Details

Device IDK182284
510k NumberK182284
Device Name:Tyber Medical PT Interbody Spacer
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant Tyber Medical LLC 83 South Commerce Way, Suite 310 Bethlehem,  PA  18017
ContactMark F. Schenk
CorrespondentMark F. Schenk
Tyber Medical LLC 83 South Commerce Way, Suite 310 Bethlehem,  PA  18017
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-23
Decision Date2019-01-18
Summary:summary

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