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FDA 510(k)

Kentrospine Viktr-MIS® Pedicle screw system

K 號:K252139 · 2026-09-27

決定日期2026-09-27
產品代碼NKB
諮詢委員會OR
決定Substantially Equivalent

器材摘要

Kentrospine Viktr-MIS® Pedicle screw system is the device name listed in this FDA 510(k) record. The listed applicant is Rivarp Medical Pvt., Ltd.. It received FDA 510(k) clearance on 2026-09-27 under 510(k) number K252139. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Kentrospine Viktr-MIS® Pedicle screw system?

Kentrospine Viktr-MIS® Pedicle screw system is a medical device that received FDA 510(k) clearance on 2026-09-27. The listed applicant is Rivarp Medical Pvt., Ltd.. The 510(k) number is K252139.

When did Kentrospine Viktr-MIS® Pedicle screw system receive FDA 510(k) clearance?

Kentrospine Viktr-MIS® Pedicle screw system received FDA 510(k) clearance on 2026-09-27, under 510(k) number K252139.

Who is the listed applicant for Kentrospine Viktr-MIS® Pedicle screw system?

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

What is the FDA product code for Kentrospine Viktr-MIS® Pedicle screw system?

The FDA product code for Kentrospine Viktr-MIS® Pedicle screw system is NKB.

相關臨床試驗

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相關器械(代碼:NKB)

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。

官方來源

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