FIXION INTRAMEDULLARY NAILING SYSTEM

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 Fixion Intramedullary Nailing System.

Pre-market Notification Details

Device IDK990717
510k NumberK990717
Device Name:FIXION INTRAMEDULLARY NAILING SYSTEM
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington,  DC  20004 -1109
ContactJonathan S Kahan
CorrespondentJonathan S Kahan
DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington,  DC  20004 -1109
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-04
Decision Date1999-06-02
Summary:summary

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