FDA 510(k)

增材骨科骨楔系统

K号: K153207 · 2016-09-07

决定日期2016-09-07

产品代码HRS

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

Additive Orthopaedics Bone Wedge System is the device name listed in this FDA 510(k) record. The listed applicant is Additive Orthopaedics, LLC. It received FDA 510(k) clearance on 2016-09-07 under 510(k) number K153207. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Additive Orthopaedics Bone Wedge System?

Additive Orthopaedics Bone Wedge System is a medical device that received FDA 510(k) clearance on 2016-09-07. The listed applicant is Additive Orthopaedics, LLC. The 510(k) number is K153207.

When did Additive Orthopaedics Bone Wedge System receive FDA 510(k) clearance?

Additive Orthopaedics Bone Wedge System received FDA 510(k) clearance on 2016-09-07, under 510(k) number K153207.

Who is the listed applicant for Additive Orthopaedics Bone Wedge System?

The FDA 510(k) record lists Additive Orthopaedics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Additive Orthopaedics Bone Wedge System?

The FDA product code for Additive Orthopaedics Bone Wedge System is HRS.

列明Additive Orthopaedics, LLC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。

K211076患者特异性标记引导器 K180239增材骨科患者专用3D打印骨段 K163593增材骨科拇外翻系统 K170214增材骨科锁定网格板 K160264增材骨科锤状趾矫正系统

相关器械（代码：HRS）

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。

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