FDA 510(k)

SpineEX サジタエラテラル腰椎間融合デバイス

K番号: K181531 · 2018-10-05

決定日2018-10-05

製品コードMAX

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices is the device name listed in this FDA 510(k) record. The listed applicant is Spineex, Inc.. It received FDA 510(k) clearance on 2018-10-05 under 510(k) number K181531. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices?

SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices is a medical device that received FDA 510(k) clearance on 2018-10-05. The listed applicant is Spineex, Inc.. The 510(k) number is K181531.

When did SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices receive FDA 510(k) clearance?

SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices received FDA 510(k) clearance on 2018-10-05, under 510(k) number K181531.

Who is the listed applicant for SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices?

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

What is the FDA product code for SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices?

The FDA product code for SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices is MAX.

申請者としてSpineex, Inc.を記載するその他の記録

K200816SpineEX サジタエラテラル腰椎間融合デバイス K190193SpineEX Sagittae® 横突間腰椎融合装置

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