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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
Recalls CDRH Recalls
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