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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K223915
Device Name Tactoset
Applicant
Anika Therapeutics, Inc.
32 Wiggins Ave.
Beford,  MA  01730
Applicant Contact Wei Zhao
Correspondent
MCRA, LLC
803 7th St. NW
Floor 3
Washington,  DC  20001
Correspondent Contact Mehdi Kazemzadeh-Narbat
Regulation Number888.3045
Classification Product Code
MQV  
Date Received12/29/2022
Decision Date 03/29/2023
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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