Patient Contoured Implant-PEEK (PCI-PEEK)

Patient Contoured Implant-PEEK (PCI-PEEK) is an FDA 510(k)-cleared medical device (K151382) manufactured by KLS Martin L.P.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 8, 2015. Regulation: 8.