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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Absorbable
510(k) Number K233302
Device Name OSSIOfiber® Compression Staple
Applicant
Ossio Ltd.
8 HaTochen St.
Caesarea,  IL 3079861
Applicant Contact Taly Lindner
Correspondent
MCRA, LLC
803 7th Street NW
Washington,  DC  20001
Correspondent Contact David McGurl
Regulation Number888.3030
Classification Product Code
MNU  
Date Received09/29/2023
Decision Date 11/16/2023
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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