FDA 510(k)

Nexta PEEK 钩状趾矫正系统

K号: K211996 · 2021-09-23

决定日期2021-09-23

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

Nexta PEEK Hammertoe Correction System is the device name listed in this FDA 510(k) record. The listed applicant is Nextremity Solutions, Inc.. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K211996. 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 Nexta PEEK Hammertoe Correction System?

Nexta PEEK Hammertoe Correction System is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Nextremity Solutions, Inc.. The 510(k) number is K211996.

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

Nexta PEEK Hammertoe Correction System received FDA 510(k) clearance on 2021-09-23, under 510(k) number K211996.

Who is the listed applicant for Nexta PEEK Hammertoe Correction System?

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

What is the FDA product code for Nexta PEEK Hammertoe Correction System?

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

列明Nextremity Solutions, 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。

K221610Nextra CH 套管钩状趾系统 K212979CalcShift™ 距离跟骨截骨系统 K220181StealthFix骨内固定系统 K213301InCore 距骨系统 K213530Nextra CH 套管钩状趾系统 K212640Stratum®踝关节融合板系统

查看所有 14 个设备 →

官方来源

在 FDA 数据库中查看 →

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。