AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX

AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX is an FDA 510(k)-cleared medical device (K010008) manufactured by Micronet Medical, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 15, 2001. Regulation: 8.