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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pin, fixation, smooth
510(k) Number K203465
Device Name OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design
Applicant
OSSIO Ltd.
8 HaTochen St.
Caesarea,  IL 3079861
Applicant Contact Taly Lindner
Correspondent
MCRA, LLC
1050 K Street NW, Suite 1000
Washington,  DC  20001
Correspondent Contact David McGurl
Regulation Number888.3040
Classification Product Code
HTY  
Date Received11/24/2020
Decision Date 01/06/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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