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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Hemi-, Radial, Polymer
510(k) Number K131845
Device Name ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC
Applicant
ACUMED LLC
5885 NW CORNELIUS PASS RD.
HILLSBORO,  OR  97124 -9432
Applicant Contact KARA BUDOR
Correspondent
ACUMED LLC
5885 NW CORNELIUS PASS RD.
HILLSBORO,  OR  97124 -9432
Correspondent Contact KARA BUDOR
Regulation Number888.3170
Classification Product Code
KWI  
Date Received06/21/2013
Decision Date 09/30/2013
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
Recalls CDRH Recalls
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