MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM

Rod, Fixation, Intramedullary And Accessories

DISC-O-TECH MEDICAL TECHNOLOGIES, LTD.

The following data is part of a premarket notification filed by Disc-o-tech Medical Technologies, Ltd. with the FDA for Modification To Fixion Interlocking Intramedullary Nailing System.

Pre-market Notification Details

Device IDK013449
510k NumberK013449
Device Name:MODIFICATION TO FIXION INTERLOCKING INTRAMEDULLARY NAILING SYSTEM
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 3 HASADNAOT Herzelia,  IL 46728
ContactElad Magal
CorrespondentElad Magal
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 3 HASADNAOT Herzelia,  IL 46728
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-10-17
Decision Date2001-12-19
Summary:summary

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