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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 K251309
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, Third Floor
Washington,  DC  20001
Correspondent Contact Dave McGurl
Regulation Number888.3030
Classification Product Code
MAI  
Date Received04/28/2025
Decision Date 05/27/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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