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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 K230744
Device Name Acumed Acutrak 3 Headless Compression Screw System
Applicant
Acumed, LLC
5885 NE Cornelius Pass Rd.
Hillsboro,  OR  97124
Applicant Contact Phillip Saddik
Correspondent
Acumed, LLC
5885 NE Cornelius Pass Rd.
Hillsboro,  OR  97124
Correspondent Contact Phillip Saddik
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/17/2023
Decision Date 06/09/2023
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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