TENSTAPLE ORTHOPEDIC STAPLING SYSTEM

TENSTAPLE ORTHOPEDIC STAPLING SYSTEM is an FDA 510(k)-cleared medical device (K896471) manufactured by Tenstaple, 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 July 23, 1990. Regulation: 8.