ISOLA POLYAXIAL WASHER

Appliance, Fixation, Spinal Interlaminal

DEPUY ACROMED

The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Isola Polyaxial Washer.

Pre-market Notification Details

Device IDK013441
510k NumberK013441
Device Name:ISOLA POLYAXIAL WASHER
ClassificationAppliance, Fixation, Spinal Interlaminal
Applicant DEPUY ACROMED 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
ContactLisa Gilman
CorrespondentLisa Gilman
DEPUY ACROMED 325 PARAMOUNT DR. Raynham,  MA  02767 -0350
Product CodeKWP  
Subsequent Product CodeMNH
Subsequent Product CodeMNI
CFR Regulation Number888.3050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-17
Decision Date2001-11-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10705034226880 K013441 000
10705034226873 K013441 000
10705034226866 K013441 000

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