FDA 510(k)

PEEK患者特別な頭蓋/頭蓋顔部移植体（PSCI）

K番号: K214109 · 2022-10-28

申請者Kontour(Xi’An) Medical Technology Co., Ltd.

決定日2022-10-28

製品コードGXN

諮問委員会Please provide the source text to translate.

決定大幅同等

医療機器の概要

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.

よくある質問

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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PEEK患者特別な頭蓋/頭蓋顔部移植体（PSCI）

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：GXN）

公式ソース