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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 K211002
Device Name Grappler Suture Anchor System
Applicant
Paragon 28, Inc.
14445 Grasslands Dr.
Englewood,  CO  80112
Applicant Contact Haylie Hertz
Correspondent
Paragon 28, Inc.
14445 Grasslands Dr.
Englewood,  CO  80112
Correspondent Contact Haylie Hertz
Regulation Number888.3040
Classification Product Code
MBI  
Date Received04/02/2021
Decision Date 07/07/2021
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
Recalls CDRH Recalls
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