PEEK患者特异性颅骨/颅面植入物(PSCI)
K号: K214109 · 2022-10-28
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器械摘要
常见问题
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.
相关临床试验
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相关器械（代码：GXN）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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