ORTHOFIX AXIALEXTERNAL FIXATION SYS.

Component, Traction, Invasive

CINTOR ORTHOPAEDIC DIV.

The following data is part of a premarket notification filed by Cintor Orthopaedic Div. with the FDA for Orthofix Axialexternal Fixation Sys..

Pre-market Notification Details

Device IDK802814
510k NumberK802814
Device Name:ORTHOFIX AXIALEXTERNAL FIXATION SYS.
ClassificationComponent, Traction, Invasive
Applicant CINTOR ORTHOPAEDIC DIV. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJEC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-11-07
Decision Date1980-12-10

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