Fixone Biocomposite Small 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 Small Anchor.

Pre-market Notification Details

Device IDK192032
510k NumberK192032
Device Name:Fixone Biocomposite Small Anchor
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant AJU Pharm Co., Ltd. A-207, 697, Pangyo-ro Seongnam-si,  KR 13511
ContactLee Gun Tak
CorrespondentPeter Chung
Plus Global 300 Atwood St. Pittsburgh,  PA  15213
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-30
Decision Date2020-03-03

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