Ventix Link Knotless Anchor With Inserter

Fastener, Fixation, Nondegradable, Soft Tissue

Cayenne Medical, Inc

The following data is part of a premarket notification filed by Cayenne Medical, Inc with the FDA for Ventix Link Knotless Anchor With Inserter.

Pre-market Notification Details

Device IDK180274
510k NumberK180274
Device Name:Ventix Link Knotless Anchor With Inserter
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Cayenne Medical, Inc 16597 N 92nd Street Scottsdale,  AZ  85260
ContactShima Hashemian
CorrespondentShima Hashemian
Cayenne Medical, Inc 16597 N 92nd Street Scottsdale,  AZ  85260
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-01-31
Decision Date2018-03-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00887868269387 K180274 000
00887868269370 K180274 000

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