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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, Biodegradable, Soft Tissue
510(k) Number K254055
Device Name OSSIOfiber® Suture Anchor
Applicant
OSSIO , Ltd.
8 Hatochen St.
Caesarea,  IL 3079861
Applicant Contact Taly Lindner
Correspondent
Mcra, LLC
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Dave McGurl
Regulation Number888.3030
Classification Product Code
MAI  
Date Received12/17/2025
Decision Date 02/24/2026
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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