FDA 510(k)

Peridot-PT 頸椎前方椎間盤融合系統，Peridot-PT 椎間盤融合系統

K 號：K233084 · 2023-11-21

決定日期2023-11-21

產品代碼ODP

諮詢委員會或

決定相當於

器材摘要

Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion 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 2023-11-21 under 510(k) number K233084. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system?

Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system is a medical device that received FDA 510(k) clearance on 2023-11-21. The listed applicant is Gbs Commonwealth Co., Ltd.. The 510(k) number is K233084.

When did Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system receive FDA 510(k) clearance?

Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system received FDA 510(k) clearance on 2023-11-21, under 510(k) number K233084.

Who is the listed applicant for Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion 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 Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system?

The FDA product code for Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system is ODP.

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 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 K213980珍珠珊瑚脊椎間置系統

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相關器械（代碼：ODP）

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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