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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 K213596
Device Name OSSIOfiber Compression Screw, 3.5mm
Applicant
OSSIO , Ltd.
8 Hatochen St.
Caesarea,  IL 3079861
Applicant Contact Taly Lindner
Correspondent
MCRA, LLC
803 7th St. NW
Washington,  DC  20001
Correspondent Contact David McGurl
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/12/2021
Decision Date 12/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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