GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY

Fastener, Fixation, Biodegradable, Soft Tissue

DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY

The following data is part of a premarket notification filed by Depuy Mitek, A Johnson And Johnson Company with the FDA for Gryphon Br Anchor W/proknot Technology,gryphon Peek Anchor W/ Proknot Technology.

Pre-market Notification Details

Device IDK140643
510k NumberK140643
Device Name:GRYPHON BR ANCHOR W/PROKNOT TECHNOLOGY,GRYPHON PEEK ANCHOR W/ PROKNOT TECHNOLOGY
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham,  MA  02767
ContactYayoi Fujimaki
CorrespondentYayoi Fujimaki
DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY 325 Paramount Drive Raynham,  MA  02767
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-12
Decision Date2014-07-08
Summary:summary

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