Coronet Soft Tissue Fixation System

Fastener, Fixation, Nondegradable, Soft Tissue

CoNextions Medical

The following data is part of a premarket notification filed by Conextions Medical with the FDA for Coronet Soft Tissue Fixation System.

Pre-market Notification Details

Device IDK200028
510k NumberK200028
Device Name:Coronet Soft Tissue Fixation System
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant CoNextions Medical 150 North Wright Brothers Drive Suite 560 Salt Lake City,  UT  84116
ContactMatthew Swift
CorrespondentJanice M. Hogan
Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia,  PA  19103
Product CodeMBI  
Subsequent Product CodeHTN
Subsequent Product CodeHWC
Subsequent Product CodeJDR
Subsequent Product CodeKGS
Subsequent Product CodeMAI
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-06
Decision Date2020-03-04

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