FDA 510(k)

Tornier Perform™ 病人匹配型初级反向肩胛窝和 BLUEPRINT™ 病人专用器械

K号: K211359 · 2021-11-12

决定日期2021-11-12

产品代码PHX

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

Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2021-11-12 under 510(k) number K211359. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation?

Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation is a medical device that received FDA 510(k) clearance on 2021-11-12. The listed applicant is Tornier, Inc.. The 510(k) number is K211359.

When did Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation receive FDA 510(k) clearance?

Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation received FDA 510(k) clearance on 2021-11-12, under 510(k) number K211359.

Who is the listed applicant for Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation?

FDA 510(k)记录将Tornier, Inc.列为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation?

The FDA product code for Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation is PHX.

列明Tornier, Inc.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。

K260721托尼尔高性能肩胛窝 K252788Tornier Perform™ 反向单柱肱骨窝（Perform Mono）K251686Tornier肱骨重建系统Max（Tornier HRS Max）K230352托尼尔肱骨钉和托尼尔长肱骨钉 K220914托尼尔肱骨系统 - 骨折 K220418托尼尔肩关节系统 - 无柄

查看所有 19 个设备 →

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。