NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER

NUCLEOTOME(R) II (VERSION2) TISSUE ASPIRA/CUTTER is an FDA 510(k)-cleared medical device (K914282) manufactured by Surgical Dynamics, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 18, 1991. Regulation: 8.