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

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..

Clearance details

Applicant: Kontour(XiAn) Medical Technology Co., Ltd.
Product code: Code GXN
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 ↗

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.