SureLock W Suture Anchor

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 Surelock W Suture Anchor.

Pre-market Notification Details

Device IDK151068
510k NumberK151068
Device Name:SureLock W Suture Anchor
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., SUITE 101 Scottsdale,  AZ  85260
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-04-21
Decision Date2015-07-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00887868269769 K151068 000
M543CM6127 K151068 000

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