HOFFMANN II COMPACT 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 Compact Mri External Fixation System.

Pre-market Notification Details

Device IDK053038
510k NumberK053038
Device Name:HOFFMANN II COMPACT 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  
Subsequent Product CodeJEC
Subsequent Product CodeLXT
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-27
Decision Date2005-11-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613154280209 K053038 000
04546540492692 K053038 000
04546540492708 K053038 000
04546540492715 K053038 000
04546540492722 K053038 000
04546540492739 K053038 000
04546540492746 K053038 000
04546540492753 K053038 000
04546540492906 K053038 000
04546540492913 K053038 000
04546540492920 K053038 000
04546540495129 K053038 000
07613154280162 K053038 000
07613154280186 K053038 000
04546540492685 K053038 000

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