MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)

Rod, Fixation, Intramedullary And Accessories

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 Modification To Fixion Intramedullary Nailing System (fixion Im).

Pre-market Notification Details

Device IDK032588
510k NumberK032588
Device Name:MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM)
ClassificationRod, Fixation, Intramedullary And Accessories
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 CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-08-22
Decision Date2003-09-12
Summary:summary

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