GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM

GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEM is an FDA 510(k)-cleared medical device (K935757) manufactured by Greenleaf Medical Systems, 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 April 14, 1994. Regulation: 8.