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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Biodegradable, Soft Tissue
510(k) Number K163672
Device Name Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor
Applicant
Nanova Biomaterials, Inc.
3806 Mojave Ct.
Columbia,  MO  65202
Applicant Contact ANDREW RITTS
Correspondent
Nanova Biomaterials, Inc.
3806 Mojave Ct.
Columbia,  MO  65202
Correspondent Contact ANDREW RITTS
Regulation Number888.3030
Classification Product Code
MAI  
Date Received12/27/2016
Decision Date 05/05/2017
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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