ELEOS 肢体挽救系统具有 BIOGRIP 功能
K号: K203090 · 2020-12-11
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决定日期2020-12-11
产品代码JDI
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：
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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]
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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
ELEOS Limb Salvage System featuring BIOGRIP is the device name listed in this FDA 510(k) record. The listed applicant is Onkos Surgical. It received FDA 510(k) clearance on 2020-12-11 under 510(k) number K203090. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ELEOS Limb Salvage System featuring BIOGRIP?
ELEOS Limb Salvage System featuring BIOGRIP is a medical device that received FDA 510(k) clearance on 2020-12-11. The listed applicant is Onkos Surgical. The 510(k) number is K203090.
When did ELEOS Limb Salvage System featuring BIOGRIP receive FDA 510(k) clearance?
ELEOS Limb Salvage System featuring BIOGRIP received FDA 510(k) clearance on 2020-12-11, under 510(k) number K203090.
Who is the listed applicant for ELEOS Limb Salvage System featuring BIOGRIP?
The FDA 510(k) record lists Onkos Surgical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ELEOS Limb Salvage System featuring BIOGRIP?
The FDA product code for ELEOS Limb Salvage System featuring BIOGRIP is JDI.
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Onkos Surgical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：JDI）
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。
K253515Zimmer Biomet OSS™ 骨科抢救系统 OsseoTi® 套管和增强件Biomet Orthopedics, Inc.K253434OSSTM骨科抢救系统Biomet, Inc.K252824Evolve AP 杯，世界鳍杯，世界 G-Zero 内衬和奇球股骨头Signature Orthopaedics Pty, Ltd.K243571trabecular金属髋臼翻修系统，髋臼衬垫和限制性衬垫Zimmer BiometK240783Anthology髋臼柄；CPCS髋臼柄；股骨头；R3髋臼衬垫；Spectron髋臼柄；Synergy髋臼柄Smith & Nephew, Inc.K241716全球模块化替换系统，模块化替换系统，模块化旋转铰链膝关节组件Howmedica Osteonics Corp., Dba Stryker Orthopaedics
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。
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