INTRAMEDULARY FIXATION ROD

Rod, Fixation, Intramedullary And Accessories

ACUMED, INC.

The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Intramedulary Fixation Rod.

Pre-market Notification Details

Device IDK951740
510k NumberK951740
Device Name:INTRAMEDULARY FIXATION ROD
ClassificationRod, Fixation, Intramedullary And Accessories
Applicant ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton,  OR  97005
ContactShari L Jeffers
CorrespondentShari L Jeffers
ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton,  OR  97005
Product CodeHSB  
CFR Regulation Number888.3020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-24
Decision Date1995-08-11

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