FDA 510(k)

BIOLOX Delta 骨股头，BIOLOX 选项骨股头系统

K号: K192416 · 2019-10-01

决定日期2019-10-01

产品代码LZO

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

BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2019-10-01 under 510(k) number K192416. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System?

BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System is a medical device that received FDA 510(k) clearance on 2019-10-01. The listed applicant is Zimmer GmbH. The 510(k) number is K192416.

When did BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System receive FDA 510(k) clearance?

BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System received FDA 510(k) clearance on 2019-10-01, under 510(k) number K192416.

Who is the listed applicant for BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System?

The FDA 510(k) record lists Zimmer GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System?

The FDA product code for BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System is LZO.

列明Zimmer GmbH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。

K211047CoCr 头 K200814Affixus(R) 自然钉(R) 系统肱骨钉 K200112Zimmer髋关节置换 K193099解剖肩部系统 K193050Alloclassic Zweymuller SL股骨柄，Alloclassic Zweymuller SL偏移股骨柄 K193030Avenir Muller Stem, Avenir水泥化髋关节假体

查看所有 19 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。