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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K243665
Device Name Crius PEEK Suture Anchor System (Thread-Fix Anchor); Crius PEEK Suture Anchor System (Thread-Fix Ultra Anchor); Crius PEEK Suture Anchor System (Helicoil Anchor); Crius PEEK Suture Anchor System (Pile Anchor)
Applicant
ZheJiang Decans Medical Devices Co., Ltd.
#2836 Xincheng Ave., Gaozhao St.
Xiuzhou District
Jiaxing,  CN 314031
Applicant Contact Haifeng Liu
Correspondent
ZheJiang Decans Medical Devices Co., Ltd.
#2836 Xincheng Ave., Gaozhao St.
Xiuzhou District
Jiaxing,  CN 314031
Correspondent Contact Chen Liu
Regulation Number888.3040
Classification Product Code
MBI  
Date Received11/27/2024
Decision Date 01/31/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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