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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K261057
Device Name ActivaScrew™ Cannulated COM
Applicant
Bioretec, Ltd.
Yrittäjänkulma 5
Tampere,  FI FI-33710
Applicant Contact Mari Ruotsalainen
Correspondent
Compliance Solutions (Life Sciences) , Ltd.
Yrittäjänkulma 5
Tampere,  FI FI-33710
Correspondent Contact Mari Ruotsalainen
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/31/2026
Decision Date 09/04/2026
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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