FIXION INTERLOCKING PROXIMAL FEMORAL 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 Fixion Interlocking Proximal Femoral Nailing System.

Pre-market Notification Details

Device IDK010988
510k NumberK010988
Device Name:FIXION INTERLOCKING PROXIMAL FEMORAL NAILING SYSTEM
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 555 THIRTEENTH STREET, NW Washington,  DC  20004
ContactJonathan S Kahan
CorrespondentJonathan S Kahan
DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. 555 THIRTEENTH STREET, NW Washington,  DC  20004
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-04-02
Decision Date2001-06-19
Summary:summary

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