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FDA 510(k)

奧米尼亞醫療TiBrid頸椎金屬支架，奧米尼亞醫療TiBrid側方金屬支架，奧米尼亞醫療TiBrid ALIF金屬支架，奧米尼亞醫療TiBrid PLIF金屬支架，奧米尼亞醫療TiBrid TLIF金屬支架

K 號：K190363 · 2020-02-21

申請人Omnia Medical, LLC
決定日期2020-02-21
產品代碼MAX
諮詢委員會或
決定相當於

器材摘要

Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage is the device name listed in this FDA 510(k) record. The listed applicant is Omnia Medical, LLC. It received FDA 510(k) clearance on 2020-02-21 under 510(k) number K190363. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage?

Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is Omnia Medical, LLC. The 510(k) number is K190363.

When did Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage receive FDA 510(k) clearance?

Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage received FDA 510(k) clearance on 2020-02-21, under 510(k) number K190363.

Who is the listed applicant for Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage?

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

What is the FDA product code for Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage?

The FDA product code for Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage is MAX.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Omnia Medical, 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。

K242431奧米尼亞醫療 PsiF DNA™ 系統K240623奧米尼亞醫療TiBrid™-SA系統K230424奧米尼亞醫療連接器-A™ 前腰部板系統；奧米尼亞醫療連接器-L™ 側腰部板系統K223321奧米尼亞醫療連接器-C 頸椎前板K212612奧米尼亞醫療 TiBrid-SCK203207奧米尼亞醫療 TiBrid-SA

查看所有 11 項裝置 →

相關器械（代碼：MAX）

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。

K261049SCALA® TLSpineart SAK261430TruLift可擴展系統Life Spine, Inc.K253011Catalyft PL 可擴展椎間體系統Medtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L脊椎系統Medtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SystemSeaSpine Orthopedics CorporationK253151Fule間體融合籠架系統Beijing Fule Science & Technology Development Co., Ltd.

官方來源

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