FDA 510(k)

Medtronic 运输/灭菌托盘

K号: K152241 · 2016-01-20

决定日期2016-01-20

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

Medtronic Transportation/Sterilization Cassettes is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2016-01-20 under 510(k) number K152241. 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 Medtronic Transportation/Sterilization Cassettes?

Medtronic Transportation/Sterilization Cassettes is a medical device that received FDA 510(k) clearance on 2016-01-20. The listed applicant is Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K152241.

When did Medtronic Transportation/Sterilization Cassettes receive FDA 510(k) clearance?

Medtronic Transportation/Sterilization Cassettes received FDA 510(k) clearance on 2016-01-20, under 510(k) number K152241.

Who is the listed applicant for Medtronic Transportation/Sterilization Cassettes?

FDA 510(k)记录中列出Medtronic Sofamor Danek USA, 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 Medtronic Transportation/Sterilization Cassettes?

The FDA product code for Medtronic Transportation/Sterilization Cassettes is KCT.

列明Medtronic Sofamor Danek USA, 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。

K253011Catalyft PL 可扩张椎间系统 K261020Symmetrix™ L 脊柱系统 K253656OsteoCool™ RF 烧灼系统；OsteoCool™ 2.0 RF 烧灼系统 K260216CD Horizon™ ModuLeX™ 穿孔螺钉套装；CD Horizon™ ModuLeX™ 脊柱系统 K254165Infinity® OCT System K253941CD Horizon™ ModuLeX™ 脊柱系统（LigaMAS 头组件）

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