510(k) K151382

Patient Contoured Implant-PEEK (PCI-PEEK) by KLS Martin L.P. — Product Code GXN

K151382 is an FDA 510(k) premarket notification submitted by KLS Martin L.P. for the device "Patient Contoured Implant-PEEK (PCI-PEEK)". The FDA issued a decision of Substantially Equivalent on November 9, 2015. The device falls under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable), a Class II device regulated under 21 CFR 882.5330. KLS Martin L.P. has at least 10 other 510(k) clearances on record.