FDA 510(k)

UTS干细胞

K号: K172251 · 2017-10-24

决定日期2017-10-24

产品代码LPH

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

UTS Stem is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corporation. It received FDA 510(k) clearance on 2017-10-24 under 510(k) number K172251. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the UTS Stem?

UTS Stem is a medical device that received FDA 510(k) clearance on 2017-10-24. The listed applicant is United Orthopedic Corporation. The 510(k) number is K172251.

When did UTS Stem receive FDA 510(k) clearance?

UTS Stem received FDA 510(k) clearance on 2017-10-24, under 510(k) number K172251.

Who is the listed applicant for UTS Stem?

FDA 510(k)记录中列出联合骨科公司为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for UTS Stem?

The FDA product code for UTS Stem is LPH.