Medical Device Manufacturer · CN , Xi'An

Kontour(Xi?An) Medical Technology Co., Ltd. - FDA 510(k) Cleared Devi...

1 submissions · 1 cleared · Since 2022

Recent clearances: PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Kontour(Xi?An) Medical Technology Co., Ltd. Neurology ✕

1 devices

1-1 of 1

Cleared Oct 28, 2022

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

Neurology · 303d

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: May 20, 2026