
Kyphon, Inc.
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DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B is an FDA 510(k)-cleared medical device (K063071) manufactured by Kyphon, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 12, 2007. Regulation: 8.