TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON

TSRH(R) TOP TIGHT T-BOLT-VARI ANGLE/SCREW/PARAGON is an FDA 510(k)-cleared medical device (K933205) manufactured by Danek Medical, 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 May 3, 1994. Regulation: 8.