
Boston Brace Intl., Inc.
Free shipping on orders over $99 · 30-day returns
STATIC CRANIOPLASTY ORTHOSIS is an FDA 510(k)-cleared medical device (K063098) manufactured by Boston Brace Intl., Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 10, 2007. Regulation: 8.