ACUTRAK PLUS FIXATION SYSTEM

Screw, Fixation, Bone

ACUMED, INC.

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

Pre-market Notification Details

Device IDK944330
510k NumberK944330
Device Name:ACUTRAK PLUS FIXATION SYSTEM
ClassificationScrew, Fixation, Bone
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 CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-06
Decision Date1995-05-05

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