HFD100 Rocker Arm Accessory

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K141950 ↗

FDA Product Code

HBL

Device Class

Class II

Regulation

21 CFR Part 882.4460

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• SYMBIS Surgical System

  Class II

  FDA 510(k) K143420 Active Cleared 30 Oct 2015

• Neuro II-Se, Models or-Mb-Dr and or-Dr

  Class II

  FDA 510(k) K061916 Active Cleared 11 Aug 2006

• Ict

  Class II

  FDA 510(k) K130224 Active Cleared 18 Jul 2013

• Imrx

  Class II

  FDA 510(k) K091166 Active Cleared 2 Sep 2009

• Imrx System V1 and Imrisnv/Imriscardio Open recall

  Class II

  FDA 510(k) K101813 Active Cleared 5 Oct 2010

• Neuro III-Sv Open recall

  Class II

  FDA 510(k) K083137 Active Cleared 16 Dec 2008

See all devices from Imris, Inc. →

• What is the HFD100 Rocker Arm Accessory used for?

  The HFD100 Rocker Arm Accessory is designed to immobilize the head during surgical procedures by supporting patient positioning in prone, supine, or lateral orientations and enabling multiple pinning configurations when used with the HFD100 Head Fixation Device system.

• How many pinning configurations does the HFD100 Rocker Arm Accessory support?

  The HFD100 Rocker Arm Accessory enables 6 different pinning configurations and offers 4-pin fixation to distribute skull clamp pressure across an additional point when used with the HFD100 system.

• Is the HFD100 Rocker Arm Accessory compatible with MRI systems?

  Yes, the HFD100 Rocker Arm Accessory is MR conditional for both 1.5T and 3T field systems, allowing safe use in MRI environments when used with compatible IMRIS imaging coils and OR tables.

• What imaging coils is the HFD100 Rocker Arm Accessory compatible with?

  The HFD100 Rocker Arm Accessory is compatible with IMRIS HC150 and HC300 flexible imaging coils, as well as InSitu wireless imaging coils, via a standard two-hole interface to IMRIS OR tables.

• Are skull pins included with the HFD100 Rocker Arm Accessory?

  No, skull pins must be ordered separately; the HFD100 Rocker Arm Accessory does not include skull pins and requires them to be sourced independently for use in fixation.