M6-C™ 单次使用，一次性器械
K 號：K241117 · 2024-06-21
廣告
器材摘要
M6-C™ Single Use, Disposable Instrumentation is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Kinetics / Orthofix / Seaspine. It received FDA 510(k) clearance on 2024-06-21 under 510(k) number K241117. The device is classified under product code QLQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the M6-C™ Single Use, Disposable Instrumentation?
M6-C™ Single Use, Disposable Instrumentation is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Spinal Kinetics / Orthofix / Seaspine. The 510(k) number is K241117.
When did M6-C™ Single Use, Disposable Instrumentation receive FDA 510(k) clearance?
M6-C™ Single Use, Disposable Instrumentation received FDA 510(k) clearance on 2024-06-21, under 510(k) number K241117.
Who is the listed applicant for M6-C™ Single Use, Disposable Instrumentation?
The FDA 510(k) record lists Spinal Kinetics / Orthofix / Seaspine as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for M6-C™ Single Use, Disposable Instrumentation?
The FDA product code for M6-C™ Single Use, Disposable Instrumentation is QLQ.
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。
相關器械（代碼：QLQ）
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。
K262639BAGUERA® C 頸椎盤手術器械Spineart SAK253392Synergy Disc 裝置Synergy Spine Solutions, Inc.K250554prodisc® L 製備醫療設備規範文本Centinel Spine, LLCK242869prodisc® L 製備醫療設備規範文本Centinel Spine, LLCK231769activL® 新一代儀器設備Aesculap Implants Systems, LLCK221848prodisc C SK、prodisc C Nova 及 prodisc C Vivo 裝置Centinel Spine, LLC
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
廣告