ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC

ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC is an FDA 510(k)-cleared medical device (K131845) manufactured by Acumed, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 29, 2013. Regulation: 8.