Consulting Wallah › Device Explorer › Other devices › Head/neck procedure positioner
Device Explorer · FDA GUDID · GMDN 40898

Head/neck procedure positioner

A noninvasive device consisting of fixed or adjustable elements (e.g., helmet, frame, board, multi-jointed structure) designed to ensure adequate support, positioning and immobilization of the patient's head, neck, and cervical spine typically during intraoper

US‑registered devices388in commercial distribution
Companies20labelers on GUDID
Single‑use51%of device records
Sterile0%labelled sterile
Prescription16%Rx‑only share
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Share of device records

Orfit Industries Nv20352%
Neurologica Corp.3910%
Mizuho Orthopedic Systems, Inc.369%
Blessing Cathay Corporation246%
Aadco Medical, Inc.236%
Mizuho Corporation164%
Plasdent Corporation123%
Klarity Medical Products, Llc72%

Top labelers

CompanyDevicesShare
Orfit Industries Nv20352%
Neurologica Corp.3910%
Mizuho Orthopedic Systems, Inc.369%
Blessing Cathay Corporation246%
Aadco Medical, Inc.236%
Mizuho Corporation164%
Plasdent Corporation123%
Klarity Medical Products, Llc72%
Schuerch Corporation41%
Skytron Llc41%
Pivotal Health Solutions, Inc.31%
Qfix31%

Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Orfit IndustriesEfficast/Nanor HybridEfficastNarrow head sectionHead ExtensionHead SupporterU-shaped Head RestBlessing CathayTarget PositionerFrameless Radiosurgery ComponentsRetrofit kit head fixation IIRetrofit kit head fixation IBlock-4-BiteElectric Epidural Positioning DeviceElectric Epidural Positioning DeviceEpidural Positioning Device

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
IYEAccelerator, linear, medical203
JAKSystem, X-Ray, Tomography, Computed42
JEATable, Surgical With Orthopedic Accessories, Ac-Powered39
IYEAccelerator, Linear, Medical32
LWGSurgical Table Cushion27
IWYHolder, Head, Radiographic25

GMDN & GCC registration

  • GMDN code 40898 · non‑implantable
  • Single‑use 51% · sterile 0% · Rx‑only 16% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 16

Use these as the dimensions to specify in a tender line.

How many head/neck procedure positioner products are registered in the US?

388 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Head/neck procedure positioner", from 20 companies. The largest labeler is Orfit Industries Nv with 52% of records.

Which FDA product codes apply?

IYE (Accelerator, linear, medical), JAK (System, X-Ray, Tomography, Computed), JEA (Table, Surgical With Orthopedic Accessories, Ac-Powered), IYE (Accelerator, Linear, Medical)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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