Doro Headrest System

• • Ongoing Z-1860-2025 FDA Class II ·initiated 14 Mar 2025

  Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.

• • Terminated Z-0193-2018 FDA Class II ·initiated 2 Nov 2017

  The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures. The breakage occurred at the very distal end of the conical part of the skull pin tip.

510(k) Number

K001808 ↗

FDA Product Code

HBL

Device Class

Class II

Regulation

21 CFR Part 882.4460

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Doro Radiolucent Headrest System ( Also MRI-Compatible) and Components

  Class II

  FDA 510(k) K063494 Active Cleared 21 May 2007

• Doro Radiolucent Headrest System and Horseshoe Headrests, and Non-Radiolucent J-Arm Retractor System (Aluminum Alloy)

  Class II

  FDA 510(k) K032331 Active Cleared 20 Nov 2003

• DORO LUCENT® iXI and iMRI Headrest System

  Class II

  FDA 510(k) K191740 Active Cleared 21 Feb 2020

• Doro Non-Stick Bipolar Forceps, Model 5001-Xx to 5012-Xx, Doro Bipolar Reusable Cables, Model 5015-Xx

  Class II

  FDA 510(k) K070997 Active Cleared 16 May 2007

• DORO QR3 XTom Headholder System

  Class II

  FDA 510(k) K191979 Active Cleared 22 Oct 2019

• DORO Sterile Disposable Skull Pins (36 pcs) (3006-00, 3006-10, 3006-20, 3006-30, 3006-50)

  Class II

  CE/MDR 1000297665 Active Valid to Jul 2028 FDA 510(k) K241883 Active Cleared 26 Jul 2024 +1authorizations

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