FDA 510(k)

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)

Número K: K214109 · 2022-10-28

RequerenteKontour(Xi’An) Medical Technology Co., Ltd.

Data da decisão2022-10-28

Código do produtoGXN

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) is the device name listed in this FDA 510(k) record. The listed applicant is Kontour(Xi’An) Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-10-28 under 510(k) number K214109. The device is classified under product code GXN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)?

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is Kontour(Xi’An) Medical Technology Co., Ltd.. The 510(k) number is K214109.

When did PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) receive FDA 510(k) clearance?

PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) received FDA 510(k) clearance on 2022-10-28, under 510(k) number K214109.

Who is the listed applicant for PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)?

The FDA 510(k) record lists Kontour(Xi’An) Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)?

The FDA product code for PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) is GXN.

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