FDA 510(k)

TRIGEN MAX 胫骨钉系统；INTERTAN MAX 髋部骨折钉系统

K号: K240061 · 2024-09-20

决定日期2024-09-20

产品代码JDS

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

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2024-09-20 under 510(k) number K240061. The device is classified under product code JDS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System?

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K240061.

When did TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System receive FDA 510(k) clearance?

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System received FDA 510(k) clearance on 2024-09-20, under 510(k) number K240061.

Who is the listed applicant for TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System?

FDA 510(k)记录中列出Smith & Nephew, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System?

The FDA product code for TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System is JDS.

列明Smith & Nephew, 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。

K261462LANDMARK 全膝关节系统 K261968Q-FIX KNOTLESS 全缝合锚，2.8mm，带一个黑色无结和一根蓝色 MINITAPE 缝线（72205981）；Q-FIX KNOTLESS 全缝合锚，2.8mm，带一个蓝色无结和一根黑色 MINITAPE 缝线（72205982）K254084AETOS ǽ - CONCELOC Glenoids K252416AETOS ǽ Meta ʽ K252129AETOS ǽ ʽ K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (编织蓝色)；BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (编织黑色)；BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (白色)；BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (编织黑色)；BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (编织蓝色)

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