meddevicedb.com FDA Device Reference

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

K214109 Class II Traditional
Decision Date
2022-10-28
Sponsor / Applicant
Kontour(Xi’An) Medical Technology Co., Ltd.

Technical Specification

510(k) Submission ID K214109
Product Code GXN
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.5330
Decision Date 2022-10-28
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) received FDA 510(k) clearance under submission number K214109, sponsored by Kontour(Xi’An) Medical Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2022-10-28.

Classification & Regulation

This clearance is catalogued under FDA product code GXN and 21 CFR 882.5330, within the Neurology review panel as a Class II device.