510(k) Report

Devices descending from K151382

2 later devices reach Patient Contoured Implant-PEEK (PCI-PEEK) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252573KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…KLS-Martin L.P.20250—
+1K214109PEEK Patient Specific Cranial/Craniofacial Implant (PSCI)Kontour (Xi’An) Medical Technology Co., Ltd.20220—