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FDA 510(k)

QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments

K 號：K161591 · 2016-09-21

申請人Globus Medical, Inc.
決定日期2016-09-21
產品代碼NKG
諮詢委員會OR
決定Substantially Equivalent

器材摘要

QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Globus Medical, Inc.. It received FDA 510(k) clearance on 2016-09-21 under 510(k) number K161591. 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 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments?

QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments is a medical device that received FDA 510(k) clearance on 2016-09-21. The listed applicant is Globus Medical, Inc.. The 510(k) number is K161591.

When did QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments receive FDA 510(k) clearance?

QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments received FDA 510(k) clearance on 2016-09-21, under 510(k) number K161591.

Who is the listed applicant for QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments?

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

What is the FDA product code for QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments?

The FDA product code for QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments is NKG.

相關臨床試驗

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其他以 Globus Medical, Inc. 為申請人之記錄

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相關器械（代碼：NKG）

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。

K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AGK253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.

官方來源

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