FDA 510(k)

OLYMPIC 导航工具

K号: K172166 · 2018-04-27

决定日期2018-04-27

产品代码OLO

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决定实质等同

器械摘要

OLYMPIC Navigated Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical. It received FDA 510(k) clearance on 2018-04-27 under 510(k) number K172166. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OLYMPIC Navigated Instruments?

OLYMPIC Navigated Instruments is a medical device that received FDA 510(k) clearance on 2018-04-27. The listed applicant is Astura Medical. The 510(k) number is K172166.

When did OLYMPIC Navigated Instruments receive FDA 510(k) clearance?

OLYMPIC Navigated Instruments received FDA 510(k) clearance on 2018-04-27, under 510(k) number K172166.

Who is the listed applicant for OLYMPIC Navigated Instruments?

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

What is the FDA product code for OLYMPIC Navigated Instruments?

The FDA product code for OLYMPIC Navigated Instruments is OLO.

列明Astura Medical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。

K252885OLYMPIC 后路脊柱固定系统; MASADA 模块化脊柱固定系统 K252346OLYMPIC 后路脊柱固定系统; MASADA 模块化脊柱固定系统 K243259MASADA Modular Spinal Fixation System K240160EGPS导航工具 K233359DOMINION可扩张椎体切除术系统 K231694MASADA Modular Spinal Fixation System

查看所有 21 个设备 →

官方来源

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