Fix2Lock (PEEK Self Punching)

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 Fix2lock (peek Self Punching).

Pre-market Notification Details

Device IDK202763
510k NumberK202763
Device Name:Fix2Lock (PEEK Self Punching)
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Osteonic Co., Ltd. 38 Digital-ro 29-gil Guro-gu,  KR 08381
ContactDa Kyung Ham
CorrespondentSanglok Lee
Wise Company Inc. #303, 142, Gasan Digital 1-ro Geumcheon-gu,  KR 08507
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-21
Decision Date2021-06-04

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