CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5

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 Cufflink(tm) Knotless Anchor With Inserter, 4.5mm/5.5mm - Peek Only, Cufflink Sp(tm) Knotless Anchor With Inserter, 4.5.

Pre-market Notification Details

Device IDK112876
510k NumberK112876
Device Name:CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant CAYENNE MEDICAL, INC. 16597 N. 92ND STREET SUITE 101 Scottsdale,  AZ  85260
ContactKereshmeh Shahriari
CorrespondentKereshmeh Shahriari
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 Received2011-09-30
Decision Date2011-12-15
Summary:summary

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