EXTERNAL FIXATOR

Component, Traction, Invasive

ACUMED, INC.

The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for External Fixator.

Pre-market Notification Details

Device IDK943857
510k NumberK943857
Device Name:EXTERNAL FIXATOR
ClassificationComponent, Traction, Invasive
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 CodeJEC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-08
Decision Date1995-01-27

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