MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM

Staple, Fixation, Bone

MITEK WORLDWIDE

The following data is part of a premarket notification filed by Mitek Worldwide with the FDA for Mitek Rapidloc-pds Meniscal Repair System.

Pre-market Notification Details

Device IDK023388
510k NumberK023388
Device Name:MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM
ClassificationStaple, Fixation, Bone
Applicant MITEK WORLDWIDE 249 VANDERBILT AVE. Norwood,  MA  02062
ContactPetra C Smit
CorrespondentPetra C Smit
MITEK WORLDWIDE 249 VANDERBILT AVE. Norwood,  MA  02062
Product CodeJDR  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-09
Decision Date2002-12-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10886705010202 K023388 000
10886705010196 K023388 000
10886705010189 K023388 000

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