FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)

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

DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD.

The following data is part of a premarket notification filed by Disco-o-tech Medical Technologies, Ltd. with the FDA for Fixion Dynamic Hip Screw System (fixion Dhs).

Pre-market Notification Details

Device IDK031401
510k NumberK031401
Device Name:FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS)
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. 3 HASADNOAT ST. Herzlia,  IL 46728
ContactYael Rubin
CorrespondentYael Rubin
DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. 3 HASADNOAT ST. Herzlia,  IL 46728
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-05-05
Decision Date2003-08-06
Summary:summary

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