FDA 510(k)

SnapHammer 拇趾矫正系统

K号: K231453 · 2024-02-16

申请人Nvision Biomedical Technologies, Inc.

决定日期2024-02-16

产品代码HWC

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

SnapHammer Hammertoe Correction System is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, Inc.. It received FDA 510(k) clearance on 2024-02-16 under 510(k) number K231453. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the SnapHammer Hammertoe Correction System?

SnapHammer Hammertoe Correction System is a medical device that received FDA 510(k) clearance on 2024-02-16. The listed applicant is Nvision Biomedical Technologies, Inc.. The 510(k) number is K231453.

When did SnapHammer Hammertoe Correction System receive FDA 510(k) clearance?

SnapHammer Hammertoe Correction System received FDA 510(k) clearance on 2024-02-16, under 510(k) number K231453.

Who is the listed applicant for SnapHammer Hammertoe Correction System?

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

What is the FDA product code for SnapHammer Hammertoe Correction System?

The FDA product code for SnapHammer Hammertoe Correction System is HWC. This falls under the Cardiovascular category.

列明Nvision Biomedical Technologies, 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。

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