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FDA 510(k)

Tiger 2 System

K 號：K253943 · 2026-07-24

申請人Zavation Medical Products, LLC
決定日期2026-07-24
產品代碼NKB
諮詢委員會OR
決定Substantially Equivalent

器材摘要

Tiger 2 System is the device name listed in this FDA 510(k) record. The listed applicant is Zavation Medical Products, LLC. It received FDA 510(k) clearance on 2026-07-24 under 510(k) number K253943. 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 Tiger 2 System?

Tiger 2 System is a medical device that received FDA 510(k) clearance on 2026-07-24. The listed applicant is Zavation Medical Products, LLC. The 510(k) number is K253943.

When did Tiger 2 System receive FDA 510(k) clearance?

Tiger 2 System received FDA 510(k) clearance on 2026-07-24, under 510(k) number K253943.

Who is the listed applicant for Tiger 2 System?

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

What is the FDA product code for Tiger 2 System?

The FDA product code for Tiger 2 System is NKB.

相關臨床試驗

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其他以 Zavation Medical Products, 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。

K243908Tiger 2 SystemK233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF SystemK231811Zavation Connector SystemK223808Zavation Navigation Instrument SystemK230731Zavation ALIF SystemK221726Uni-FuZe-C Bone Strip

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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。

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

官方來源

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