FDA 510(k)

DVR® Crosslock 腕部支撑板 (131849181)

K号: K220244 · 2022-04-28

申请人Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech

决定日期2022-04-28

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

DVR® Crosslock Wrist Spanning Plate (131849181) is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech. It received FDA 510(k) clearance on 2022-04-28 under 510(k) number K220244. 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 DVR® Crosslock Wrist Spanning Plate (131849181)?

DVR® Crosslock Wrist Spanning Plate (131849181) is a medical device that received FDA 510(k) clearance on 2022-04-28. The listed applicant is Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech. The 510(k) number is K220244.

When did DVR® Crosslock Wrist Spanning Plate (131849181) receive FDA 510(k) clearance?

DVR® Crosslock Wrist Spanning Plate (131849181) received FDA 510(k) clearance on 2022-04-28, under 510(k) number K220244.

Who is the listed applicant for DVR® Crosslock Wrist Spanning Plate (131849181)?

The FDA 510(k) record lists Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DVR® Crosslock Wrist Spanning Plate (131849181)?

The FDA product code for DVR® Crosslock Wrist Spanning Plate (131849181) is HRS.

列明Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech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。

K230993CODA™前颈椎板系统

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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