FDA 510(k)

高原間隔系統

K 號：K182470 · 2018-11-26

決定日期2018-11-26

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Plateau Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Life Spine. It received FDA 510(k) clearance on 2018-11-26 under 510(k) number K182470. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Plateau Spacer System?

Plateau Spacer System is a medical device that received FDA 510(k) clearance on 2018-11-26. The listed applicant is Life Spine. The 510(k) number is K182470.

When did Plateau Spacer System receive FDA 510(k) clearance?

Plateau Spacer System received FDA 510(k) clearance on 2018-11-26, under 510(k) number K182470.

Who is the listed applicant for Plateau Spacer System?

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

What is the FDA product code for Plateau Spacer System?

The FDA product code for Plateau Spacer System is MAX.

其他以 Life Spine 為申請人之記錄

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K160169生命脊柱足弓植入系統

相關器械（代碼：MAX）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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