FDA 510(k)

Ennovate脊椎頸部及枕骨系統

K 號：K213871 · 2022-07-01

決定日期2022-07-01

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

Ennovate Cervical Spinal and Occiput System is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implant Systems, LLC. It received FDA 510(k) clearance on 2022-07-01 under 510(k) number K213871. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Ennovate Cervical Spinal and Occiput System?

Ennovate Cervical Spinal and Occiput System is a medical device that received FDA 510(k) clearance on 2022-07-01. The listed applicant is Aesculap Implant Systems, LLC. The 510(k) number is K213871.

When did Ennovate Cervical Spinal and Occiput System receive FDA 510(k) clearance?

Ennovate Cervical Spinal and Occiput System received FDA 510(k) clearance on 2022-07-01, under 510(k) number K213871.

Who is the listed applicant for Ennovate Cervical Spinal and Occiput System?

The FDA 510(k) record lists Aesculap Implant Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ennovate Cervical Spinal and Occiput System?

The FDA product code for Ennovate Cervical Spinal and Occiput System is NKG.

其他以 Aesculap Implant Systems, LLC 為申請人之記錄

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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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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