HOFFMANN II MRI EXTERNAL FIXATION SYSTEM

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

HOWMEDICA OSTEONICS CORP

The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Hoffmann Ii Mri External Fixation System.

Pre-market Notification Details

Device IDK053472
510k NumberK053472
Device Name:HOFFMANN II MRI EXTERNAL FIXATION SYSTEM
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
ContactVivian Kelly
CorrespondentVivian Kelly
HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-12-14
Decision Date2006-01-11
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613154317745 K053472 000
07613154317738 K053472 000
07613154317721 K053472 000
07613154317714 K053472 000
04546540495136 K053472 000
04546540495112 K053472 000
04546540495105 K053472 000
04546540492555 K053472 000

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