ACUMED TENSION BAND PIN

Pin, Fixation, Smooth

ACUMED, INC.

The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Acumed Tension Band Pin.

Pre-market Notification Details

Device IDK964500
510k NumberK964500
Device Name:ACUMED TENSION BAND PIN
ClassificationPin, Fixation, Smooth
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 CodeHTY  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-08
Decision Date1996-12-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10806378015700 K964500 000
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10806378015731 K964500 000
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10806378042003 K964500 000
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10806378088155 K964500 000
10806378089763 K964500 000
10806378089770 K964500 000
10806378089787 K964500 000
10806378085437 K964500 000

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