CoNextions TR Tendon Repair System

Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

CoNextions Medical

The following data is part of a premarket notification filed by Conextions Medical with the FDA for Conextions Tr Tendon Repair System.

Pre-market Notification Details

Device IDK203855
510k NumberK203855
Device Name:CoNextions TR Tendon Repair System
ClassificationSuture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
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 CodeGAQ  
CFR Regulation Number878.4495 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-31
Decision Date2022-04-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10861445000324 K203855 000
10861445000317 K203855 000
10861445000300 K203855 000

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.