Sterile Bioabsorbable Bone Screw (Bioabsorbable ACL Screw)

Fastener, Fixation, Biodegradable, Soft Tissue

Osteonic Co., Ltd.

The following data is part of a premarket notification filed by Osteonic Co., Ltd. with the FDA for Sterile Bioabsorbable Bone Screw (bioabsorbable Acl Screw).

Pre-market Notification Details

Device IDK210122
510k NumberK210122
Device Name:Sterile Bioabsorbable Bone Screw (Bioabsorbable ACL Screw)
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant Osteonic Co., Ltd. 39 Digital-ro 29-gil Guro-gu,  KR 08381
ContactDa Kyung Ham
CorrespondentSanglok Lee
Wise Company Inc. #507, #508, 166 Gasan Digital 2-ro Geumcheon-gu,  KR 08507
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-19
Decision Date2021-08-27

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