
Synthes Spine Co.Lp
Free shipping on orders over $99 · 30-day returns
SYNTHES PANGEA MONOAXIAL SYSTEM is an FDA 510(k)-cleared medical device (K052151) manufactured by Synthes Spine Co.Lp. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 6, 2005. Regulation: 8.