
Pisharodi Surgicals, Inc.
Free shipping on orders over $99 · 30-day returns
MODIFICATION TO UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM is an FDA 510(k)-cleared medical device (K024313) manufactured by Pisharodi Surgicals, 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 August 28, 2003. Regulation: 8.