QUANTUM M COMPOSITE NAILING SYSTEM

Rod, Fixation, Intramedullary And Accessories

N.M.B. MEDICAL APPLICATIONS, LTD.

The following data is part of a premarket notification filed by N.m.b. Medical Applications, Ltd. with the FDA for Quantum M Composite Nailing System.

Pre-market Notification Details

Device IDK091425
510k NumberK091425
Device Name:QUANTUM M COMPOSITE NAILING SYSTEM
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant N.M.B. MEDICAL APPLICATIONS, LTD. 555 THIRTEENTH ST. NW Washington,  DC  20004
ContactJonathan S Kahan
CorrespondentJonathan S Kahan
N.M.B. MEDICAL APPLICATIONS, LTD. 555 THIRTEENTH ST. NW Washington,  DC  20004
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-05-13
Decision Date2010-01-21
Summary:summary

NIH GUDID Devices

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