FDA 510(k)

补充器械托盘

K号: K170939 · 2017-08-08

申请人Nuvasive Specialized Orthopedics, Incorporated

决定日期2017-08-08

产品代码KCT

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Supplemental Instrument Trays is the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive Specialized Orthopedics, Incorporated. It received FDA 510(k) clearance on 2017-08-08 under 510(k) number K170939. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Supplemental Instrument Trays?

Supplemental Instrument Trays is a medical device that received FDA 510(k) clearance on 2017-08-08. The listed applicant is Nuvasive Specialized Orthopedics, Incorporated. The 510(k) number is K170939.

When did Supplemental Instrument Trays receive FDA 510(k) clearance?

Supplemental Instrument Trays received FDA 510(k) clearance on 2017-08-08, under 510(k) number K170939.

Who is the listed applicant for Supplemental Instrument Trays?

The FDA 510(k) record lists Nuvasive Specialized Orthopedics, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Supplemental Instrument Trays?

The FDA product code for Supplemental Instrument Trays is KCT.

列明Nuvasive Specialized Orthopedics, Incorporated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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