PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)— 510(k) K214109

Name: FDA 510(k) clearance K214109
Creator: U.S. Food and Drug Administration
Published: 2022-10-28

Substantially Equivalent

Kontour(XiAn) Medical Technology Co., Ltd.

FDA 510(k) clearance K214109 for PEEK Patient Specific Cranial/Craniofacial Implant(PSCI), Substantially Equivalent on 2022-10-28. Applicant: Kontour(XiAn) Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Kontour(XiAn) Medical Technology Co., Ltd.
Product code: Code GXN
Device class: Class 2
Regulation: 21 CFR 882.5330
Advisory panel: Neurology
Date received: 2021-12-29
Decision date: 2022-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xi'An, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code GXN

view all

K260709 — ClearFit Ti Ring 14mm (171750) +4 more2026-06-25
K253116 — 3D MAC Titanium Cranial Plate (TCP) System2026-06-18
K252251 — EASYMADE-TI2026-04-09
K252958 — METICULY Patient-specific titanium mesh implant2026-01-14
K243715 — Synthes Patient Specific Implants2025-11-12

Adverse events under product code GXN

product code GXN

Injury: 208
Total: 208

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.