Sterile Bone Screw (PEEK ACL Screw)

Fastener, Fixation, Nondegradable, Soft Tissue

Osteonic Co., Ltd.

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

Pre-market Notification Details

Device IDK202883
510k NumberK202883
Device Name:Sterile Bone Screw (PEEK ACL Screw)
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Osteonic Co., Ltd. 38 Digital-ro 29-gil Guro-gu,  KR 08381
ContactSungmoo Hwang
CorrespondentSanglok Lee
Wise Company Inc. #507-508, 166 Gasan Digital 2-ro Geumcheon-gu,  KR 08503
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-28
Decision Date2020-11-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800071019077 K202883 000
08800071019060 K202883 000
08800071019053 K202883 000
08800071019046 K202883 000
08800071019039 K202883 000
08800071019022 K202883 000
08800071019015 K202883 000
08800071019008 K202883 000

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