FDA 510(k)

Ascension 硅胶 MCP；Ascension 硅胶 PIP

K号: K233670 · 2023-12-14

决定日期2023-12-14

产品代码KYJ

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

Ascension Silicone MCP; Ascension Silicone PIP is the device name listed in this FDA 510(k) record. The listed applicant is Ascension Orthopedics, Inc.. It received FDA 510(k) clearance on 2023-12-14 under 510(k) number K233670. The device is classified under product code KYJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ascension Silicone MCP; Ascension Silicone PIP?

Ascension Silicone MCP; Ascension Silicone PIP is a medical device that received FDA 510(k) clearance on 2023-12-14. The listed applicant is Ascension Orthopedics, Inc.. The 510(k) number is K233670.

When did Ascension Silicone MCP; Ascension Silicone PIP receive FDA 510(k) clearance?

Ascension Silicone MCP; Ascension Silicone PIP received FDA 510(k) clearance on 2023-12-14, under 510(k) number K233670.

Who is the listed applicant for Ascension Silicone MCP; Ascension Silicone PIP?

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

What is the FDA product code for Ascension Silicone MCP; Ascension Silicone PIP?

The FDA product code for Ascension Silicone MCP; Ascension Silicone PIP is KYJ.

列明Ascension Orthopedics, 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。

K233674Freedom腕关节成形系统

官方来源

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