FDA 510(k)

麗光椎間盤融合設備

K 號：K152011 · 2016-06-09

決定日期2016-06-09

產品代碼MAX

諮詢委員會或

決定相當於

器材摘要

Lucent Intervertebral Body Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Elements, Inc.. It received FDA 510(k) clearance on 2016-06-09 under 510(k) number K152011. 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 Lucent Intervertebral Body Fusion Device?

Lucent Intervertebral Body Fusion Device is a medical device that received FDA 510(k) clearance on 2016-06-09. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K152011.

When did Lucent Intervertebral Body Fusion Device receive FDA 510(k) clearance?

Lucent Intervertebral Body Fusion Device received FDA 510(k) clearance on 2016-06-09, under 510(k) number K152011.

Who is the listed applicant for Lucent Intervertebral Body Fusion Device?

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

What is the FDA product code for Lucent Intervertebral Body Fusion Device?

The FDA product code for Lucent Intervertebral Body Fusion Device is MAX.

其他以 Spinal Elements, Inc. 為申請人之記錄

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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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