
Tgm Medical
Free shipping on orders over $99 · 30-day returns
HELICON HIP SYSTEM, FEMORAL STEM, HELICON HIP SYSTEM, FEMORAL HEAD, COCR, HELICON HIP SYSTEM, ACETABULAR SHELL, HELICON is an FDA 510(k)-cleared medical device (K111472) manufactured by Tgm Medical. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 5, 2011. Regulation: 8.