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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 K240594
Device Name Grappler Suture Anchor R3FLEX IOL System
Applicant
Paragon 28, Inc.
14445 Grasslands Dr.
Englewood,  CO  80112
Applicant Contact Edward Wells-Spicer
Correspondent
Paragon 28, Inc.
14445 Grasslands Dr.
Englewood,  CO  80112
Correspondent Contact Edward Wells-Spicer
Regulation Number888.3040
Classification Product Code
MBI  
Date Received03/04/2024
Decision Date 03/26/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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