FDA 510(k)

CoLink 钢板系统，骨折和矫正系统，RTS 移植物系统，NeoSpan 压缩钉系统

K号: K190385 · 2019-08-08

决定日期2019-08-08

产品代码HRS

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

CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA, LLC. It received FDA 510(k) clearance on 2019-08-08 under 510(k) number K190385. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System?

CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System is a medical device that received FDA 510(k) clearance on 2019-08-08. The listed applicant is In2bones USA, LLC. The 510(k) number is K190385.

When did CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System receive FDA 510(k) clearance?

CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System received FDA 510(k) clearance on 2019-08-08, under 510(k) number K190385.

Who is the listed applicant for CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System?

The FDA 510(k) record lists In2bones USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System?

The FDA product code for CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System is HRS.

列明In2bones USA, LLC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。

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官方来源

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