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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 K261869
Device Name Integrity Retractable Implant Inserter (6000127)
Applicant
Anika Therapeutics, Inc.
32 Wiggins Ave.
Beford,  MA  01730
Applicant Contact Calen Souther
Correspondent
Anika Therapeutics, Inc.
32 Wiggins Ave.
Beford,  MA  01730
Correspondent Contact Calen Souther
Regulation Number888.3040
Classification Product Code
MBI  
Date Received06/04/2026
Decision Date 09/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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