FDA 510(k)

prodisc C SK、prodisc C Nova 及 prodisc C Vivo 裝置

K 號：K221848 · 2022-08-19

決定日期2022-08-19

產品代碼QLQ

諮詢委員會或

決定相當於

器材摘要

prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Centinel Spine, LLC. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K221848. 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 prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments?

prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Centinel Spine, LLC. The 510(k) number is K221848.

When did prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments receive FDA 510(k) clearance?

prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments received FDA 510(k) clearance on 2022-08-19, under 510(k) number K221848.

Who is the listed applicant for prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments?

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

What is the FDA product code for prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments?

The FDA product code for prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments is QLQ.

其他以 Centinel Spine, 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。

K250554prodisc® L 製備醫療設備規範文本 K242869prodisc® L 製備醫療設備規範文本

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 SA K253392Synergy Disc 裝置Synergy Spine Solutions, Inc.K250554prodisc® L 製備醫療設備規範文本Centinel Spine, LLC K242869prodisc® L 製備醫療設備規範文本Centinel Spine, LLC K241117M6-C™ 单次使用，一次性器械Spinal Kinetics / Orthofix / Seaspine K231769activL® 新一代儀器設備Aesculap Implants Systems, LLC

官方來源

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