FDA 510(k)

IMPEACE及IMPEACE-Uni前方颈椎板系統

K 號：K220379 · 2022-03-03

決定日期2022-03-03

產品代碼KWQ

諮詢委員會或

決定相當於

器材摘要

IMPEACE and IMPEACE-Uni Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Medynus, Inc.. It received FDA 510(k) clearance on 2022-03-03 under 510(k) number K220379. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IMPEACE and IMPEACE-Uni Anterior Cervical Plate System?

IMPEACE and IMPEACE-Uni Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2022-03-03. The listed applicant is Medynus, Inc.. The 510(k) number is K220379.

When did IMPEACE and IMPEACE-Uni Anterior Cervical Plate System receive FDA 510(k) clearance?

IMPEACE and IMPEACE-Uni Anterior Cervical Plate System received FDA 510(k) clearance on 2022-03-03, under 510(k) number K220379.

Who is the listed applicant for IMPEACE and IMPEACE-Uni Anterior Cervical Plate System?

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

What is the FDA product code for IMPEACE and IMPEACE-Uni Anterior Cervical Plate System?

The FDA product code for IMPEACE and IMPEACE-Uni Anterior Cervical Plate System is KWQ.

其他以 Medynus, Inc. 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。

K212792Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK 金屬網格 K210420哥布林及哥布林LS椎板螺釘系統

相關器械（代碼：KWQ）

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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