RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM

Fastener, Fixation, Nondegradable, Soft Tissue

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 Rigidloop Fixation Device (15mm, 60mm, Xl, 20mm, 25mm, 30mm, 35mm, 40mm, 45mm, 50mm, 55mm.

Pre-market Notification Details

Device IDK130814
510k NumberK130814
Device Name:RIGIDLOOP FIXATION DEVICE (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MM
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
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 CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-25
Decision Date2013-08-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886705022809 K130814 000

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