FDA 510(k)

Materialise 肩关节系统™ Materialise 肩关节引导和模型 SurgiCase 肩关节规划器

K号: K220452 · 2022-08-17

决定日期2022-08-17

产品代码QHE

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

Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2022-08-17 under 510(k) number K220452. The device is classified under product code QHE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner?

Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner is a medical device that received FDA 510(k) clearance on 2022-08-17. The listed applicant is Materialise NV. The 510(k) number is K220452.

When did Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner receive FDA 510(k) clearance?

Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner received FDA 510(k) clearance on 2022-08-17, under 510(k) number K220452.

Who is the listed applicant for Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner?

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

What is the FDA product code for Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner?

The FDA product code for Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner is QHE.

列明Materialise NV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。

K260802Materialise肩关节系统™，Materialise肩关节引导和模型，SurgiCase肩关节规划器 K251964Mimics 胸部规划器 K253308Materialise 针对颅面外科手术的个性化引导和模型 CMF 钛制引导；CMF 塑料模型 K253793Materialise全膝关节置换术引导系统 K251554Materialise全膝关节置换术引导系统 K243637Materialise 针对颅面外科手术的个性化引导和模型

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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。