FDA 510(k)

Prase-AP 前頸板系統

K 號：K202878 · 2021-01-29

決定日期2021-01-29

產品代碼KWQ

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決定相當於

器材摘要

Prase-AP Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Gbs Commonwealth Co., Ltd.. It received FDA 510(k) clearance on 2021-01-29 under 510(k) number K202878. 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 Prase-AP Anterior Cervical Plate System?

Prase-AP Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is Gbs Commonwealth Co., Ltd.. The 510(k) number is K202878.

When did Prase-AP Anterior Cervical Plate System receive FDA 510(k) clearance?

Prase-AP Anterior Cervical Plate System received FDA 510(k) clearance on 2021-01-29, under 510(k) number K202878.

Who is the listed applicant for Prase-AP Anterior Cervical Plate System?

The FDA 510(k) record lists Gbs Commonwealth Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Prase-AP Anterior Cervical Plate System?

The FDA product code for Prase-AP Anterior Cervical Plate System is KWQ.

其他以 Gbs Commonwealth Co., Ltd. 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。

K233839Peridot-PT 頸椎間盤融合系統；Peridot-PT 間盤融合系統；Peridot-TD 頸椎間盤融合系統；Peridot-TD 間盤融合系統 K233084Peridot-PT 頸椎前方椎間盤融合系統，Peridot-PT 椎間盤融合系統 K232292Peridot-EX 可擴展椎間體融合系統 K232822Peridot-TD 间隔系統（Peridot-TD 間椎體融合系統），前頸間融合 - ACIF（Peridot-TD 前頸間椎體融合系統）K230708Peridot-TD 間隙系統（Peridot-TD 間碟體融合系統）；前頸間碟體融合-ACIF（Peridot-TD 前頸間碟體融合系統）K213755Peridot-PT 頸椎前方椎間盤融合系統，Peridot-PT 椎間盤融合系統

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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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