Ascential IBD PEEKc Spacer

Ascential IBD PEEKc Spacer is an FDA 510(k)-cleared medical device (K161407) manufactured by Stryker Spine. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 14, 2016. Regulation: 8.