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FDA 510(k)

FRAXION Spinal Fixation System

K 號：K262091 · 2026-09-17

申請人Ortler Global Tibbi Gerecler Anonim Sirketi
決定日期2026-09-17
產品代碼NKB
諮詢委員會OR
決定Substantially Equivalent

器材摘要

FRAXION Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Ortler Global Tibbi Gerecler Anonim Sirketi. It received FDA 510(k) clearance on 2026-09-17 under 510(k) number K262091. 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 FRAXION Spinal Fixation System?

FRAXION Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2026-09-17. The listed applicant is Ortler Global Tibbi Gerecler Anonim Sirketi. The 510(k) number is K262091.

When did FRAXION Spinal Fixation System receive FDA 510(k) clearance?

FRAXION Spinal Fixation System received FDA 510(k) clearance on 2026-09-17, under 510(k) number K262091.

Who is the listed applicant for FRAXION Spinal Fixation System?

The FDA 510(k) record lists Ortler Global Tibbi Gerecler Anonim Sirketi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FRAXION Spinal Fixation System?

The FDA product code for FRAXION Spinal Fixation System is NKB.

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。

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其他以 Ortler Global Tibbi Gerecler Anonim Sirketi 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。

K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)

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.K262193RIVA® 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.K253943Tiger 2 SystemZavation Medical Products, LLC

官方來源

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