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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 K181180
Device Name OSSIO™ Pin Product Family
Applicant
OSSIO , Ltd.
8 Hatochen St.
Caesarea,  IL 3088900
Applicant Contact Taly Lindner
Correspondent
Hogan Lovells US LLP
1735 Market St.
Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number888.3040
Classification Product Code
HTY  
Date Received05/02/2018
Decision Date 01/10/2019
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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