FDA 510(k)

Restor3d Utility楔

K号: K201314 · 2021-06-17

决定日期2021-06-17

产品代码PLF

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

Restor3d Utility Wedge is the device name listed in this FDA 510(k) record. The listed applicant is Restor3D, Inc.. It received FDA 510(k) clearance on 2021-06-17 under 510(k) number K201314. The device is classified under product code PLF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Restor3d Utility Wedge?

Restor3d Utility Wedge is a medical device that received FDA 510(k) clearance on 2021-06-17. The listed applicant is Restor3D, Inc.. The 510(k) number is K201314.

When did Restor3d Utility Wedge receive FDA 510(k) clearance?

Restor3d Utility Wedge received FDA 510(k) clearance on 2021-06-17, under 510(k) number K201314.

Who is the listed applicant for Restor3d Utility Wedge?

The FDA 510(k) record lists Restor3D, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Restor3d Utility Wedge?

The FDA product code for Restor3d Utility Wedge is PLF.

列明Restor3D, 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。

K252067Velora髋臼系统 K243768iTotal® Identity™ 关节保留 3DP 多孔膝关节置换系统 K242356TIDAL融合笼系统 K240591restor3d Kinos Axiom 全踝关节系统 K201393restor3d MTP植入物

官方来源

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