REPROCESSED EXTERNAL FIXATION DEVICE

Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

ASCENT HEALTHCARE SOLUTIONS

The following data is part of a premarket notification filed by Ascent Healthcare Solutions with the FDA for Reprocessed External Fixation Device.

Pre-market Notification Details

Device IDK061759
510k NumberK061759
Device Name:REPROCESSED EXTERNAL FIXATION DEVICE
ClassificationAppliance, Fixation, Nail/blade/plate Combination, Multiple Component
Applicant ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix,  AZ  85044
ContactAmanda Babcock
CorrespondentAmanda Babcock
ASCENT HEALTHCARE SOLUTIONS 10232 SOUTH 51ST ST. Phoenix,  AZ  85044
Product CodeKTT  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-22
Decision Date2006-09-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00885825020149 K061759 000

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