FDA 510(k)

T2 STRATOSPHERE™ Expandable Corpectomy System

K号: K173125 · 2017-12-20

决定日期2017-12-20

产品代码MQP

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决定实质等同

器械摘要

T2 STRATOSPHERE™ Expandable Corpectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2017-12-20 under 510(k) number K173125. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the T2 STRATOSPHERE™ Expandable Corpectomy System?

T2 STRATOSPHERE™ Expandable Corpectomy System is a medical device that received FDA 510(k) clearance on 2017-12-20. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K173125.

When did T2 STRATOSPHERE™ Expandable Corpectomy System receive FDA 510(k) clearance?

T2 STRATOSPHERE™ Expandable Corpectomy System received FDA 510(k) clearance on 2017-12-20, under 510(k) number K173125.

Who is the listed applicant for T2 STRATOSPHERE™ Expandable Corpectomy System?

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

What is the FDA product code for T2 STRATOSPHERE™ Expandable Corpectomy System?

The FDA product code for T2 STRATOSPHERE™ Expandable Corpectomy System is MQP.

列明Medtronic Sofamor Danek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。

K212428Centerpiece板固定系统 K201267Adaptix Interbody System with Titan nanoLOCK Surface Technology K172199ELEVATE 脊柱系统，CAPSTONE PTC 脊柱系统，CRESCENT 脊柱系统，CRESCENT 脊柱系统钛合金 K171031CRESCENT™ 脊柱系统 K171468FUSE 脊柱系统 K170679CD HORIZON®脊柱系统，Medtronic可重复使用工具，用于IPC® POWEREASE®系统，Medtronic导航可重复使用工具，用于STEALTHSTATION®和IPC® POWEREASE®系统

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