FDA 510(k)

QUANTUM 患者专用器械系统 (PSI)

K号: K230313 · 2023-04-06

决定日期2023-04-06

产品代码HSN

咨询委员会OR 请注意，由于原文中未提供具体的医疗设备监管文本，以下是一个示例翻译，您可以根据实际文本进行调整： --- 产品名称：[产品名称] 公司名称：[公司名称] 根据FDA 510(k)预市场批准程序，[产品名称]已获得批准，用于[产品用途描述]。产品注册号：[注册号] PMA编号：[PMA编号] 临床试验编号（NCT）：[NCT编号] PubMed ID（PMID）：[PMID编号] 更多信息请访问以下链接： [URL] --- 请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。

决定实质等同

器械摘要

QUANTUM Patient Specific Instrumentation (PSI) System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones Sas. It received FDA 510(k) clearance on 2023-04-06 under 510(k) number K230313. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the QUANTUM Patient Specific Instrumentation (PSI) System?

QUANTUM Patient Specific Instrumentation (PSI) System is a medical device that received FDA 510(k) clearance on 2023-04-06. The listed applicant is In2bones Sas. The 510(k) number is K230313.

When did QUANTUM Patient Specific Instrumentation (PSI) System receive FDA 510(k) clearance?

QUANTUM Patient Specific Instrumentation (PSI) System received FDA 510(k) clearance on 2023-04-06, under 510(k) number K230313.

Who is the listed applicant for QUANTUM Patient Specific Instrumentation (PSI) System?

The FDA 510(k) record lists In2bones Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUANTUM Patient Specific Instrumentation (PSI) System?

The FDA product code for QUANTUM Patient Specific Instrumentation (PSI) System is HSN.

列明In2bones Sas为申报人的其他记录

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。

K231699QUANTUM® 患者专用器械系统 (PSI)K211883QUANTUM® 患者专用器械系统 (PSI)K191380Quantum® 全踝关节假体 K173811TRIWAY 胫骨距骨跟骨关节融合系统 K173616DIP 骨融合系统 K170688PIT’Stop® 移植体

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官方来源

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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。