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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 K221333
Device Name Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional
Applicant
Acumed LLC
5885 NE Cornelius Pass Rd.
Hillsboro,  OR  97124
Applicant Contact Saleh Amirriyazi
Correspondent
Acumed LLC
5885 NE Cornelius Pass Rd.
Hillsboro,  OR  97124
Correspondent Contact Saleh Amirriyazi
Regulation Number888.3040
Classification Product Code
HWC  
Date Received05/09/2022
Decision Date 12/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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