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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 K193660
Device Name OSSIOfiber™ Compression Screws
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
HWC  
Date Received12/30/2019
Decision Date 07/30/2020
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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