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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K202918
Device Name OsteoSync™ Ti Dental Mesh
Applicant
Sites Medical, LLC
5865 E. State Rd. 14
Columbia City,  IN  46725
Applicant Contact Greg Stalcup
Correspondent
Backroads Consulting
P.O. Box 566
Chesterland,  OH  44026
Correspondent Contact Karen E Warden
Regulation Number872.4760
Classification Product Code
JEY  
Date Received09/29/2020
Decision Date 07/14/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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