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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, Nondegradable, Soft Tissue
510(k) Number K182264
Device Name ICONN Revolution Knotless Suture Anchor
Applicant
Iconn Orthopedics, LLC
400 Union Hill Dr., Suite 150
Birmingham,  AL  35209
Applicant Contact Whitt Israel
Correspondent
Iconn Orthopedics, LLC
400 Union Hill Dr., Suite 150
Birmingham,  AL  35209
Correspondent Contact Whitt Israel
Regulation Number888.3040
Classification Product Code
MBI  
Date Received08/21/2018
Decision Date 10/19/2018
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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