BIOKNOTLESS AND LUPINE PLUS ANCHORS

Staple, Fixation, Bone

DEPUY MITEK, A JOHNSON & JOHNSON COMPANY

The following data is part of a premarket notification filed by Depuy Mitek, A Johnson & Johnson Company with the FDA for Bioknotless And Lupine Plus Anchors.

Pre-market Notification Details

Device IDK062170
510k NumberK062170
Device Name:BIOKNOTLESS AND LUPINE PLUS ANCHORS
ClassificationStaple, Fixation, Bone
Applicant DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham,  MA  02767
ContactKristine Christo
CorrespondentKristine Christo
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeJDR  
Subsequent Product CodeHWC
Subsequent Product CodeMAI
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-07-31
Decision Date2006-08-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886705001057 K062170 000
10886705001071 K062170 000
10886705001064 K062170 000

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