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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K233198
Device Name OSSIOfiber® Threaded Trimmable Fixation Nails
Applicant
OSSIO , Ltd.
8 Hatochen St.
Caesarea,  IL 3079861
Applicant Contact Taly Lindner
Correspondent
OSSIO , Ltd.
8 Hatochen St.
Caesarea,  IL 3079861
Correspondent Contact Taly Lindner
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/28/2023
Decision Date 03/08/2024
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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