Fixone Biocomposite Anchor

Fastener, Fixation, Biodegradable, Soft Tissue

AJU Pharm Co.,Ltd.

The following data is part of a premarket notification filed by Aju Pharm Co.,ltd. with the FDA for Fixone Biocomposite Anchor.

Pre-market Notification Details

Device IDK171299
510k NumberK171299
Device Name:Fixone Biocomposite Anchor
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant AJU Pharm Co.,Ltd. A-207, 697, Pangyo-ro Seongnam-si,  KR 13511
ContactKim Jung Gil
CorrespondentPeter Chung
Plus Global 300 Atwood Pittsburgh,  PA  15213
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-03
Decision Date2017-08-24
Summary:summary

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