InCore 距骨系统
K号: K213301 · 2021-12-21
广告
决定日期2021-12-21
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
InCore Subtalar 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 2021-12-21 under 510(k) number K213301. 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 InCore Subtalar System?
InCore Subtalar System is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is Nextremity Solutions, Inc.. The 510(k) number is K213301.
When did InCore Subtalar System receive FDA 510(k) clearance?
InCore Subtalar System received FDA 510(k) clearance on 2021-12-21, under 510(k) number K213301.
Who is the listed applicant for InCore Subtalar 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 InCore Subtalar System?
The FDA product code for InCore Subtalar System is HWC. This falls under the Cardiovascular category.
相关临床试验
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。
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。
相关器械（代码：HWC）
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。
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。
广告