QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM 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 Im Composite Nailing System (quantum Nailing System).

Pre-market Notification Details

Device IDK100497
510k NumberK100497
Device Name:QUANTUM IM COMPOSITE NAILING SYSTEM (QUANTUM NAILING SYSTEM)
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant N.M.B. MEDICAL APPLICATIONS, LTD. 11 HA'HOSHLIM STREET Herzeliya,  IL 46724
ContactHila Wachsler-avrahami
CorrespondentHila Wachsler-avrahami
N.M.B. MEDICAL APPLICATIONS, LTD. 11 HA'HOSHLIM STREET Herzeliya,  IL 46724
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-22
Decision Date2010-06-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290110202088 K100497 000
07290109331898 K100497 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.