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Device Explorer · FDA GUDID · GMDN 32568

Neurological stereotactic surgery system

An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may

US‑registered devices1,744in commercial distribution
Companies31labelers on GUDID
Single‑use20%of device records
Sterile13%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Medtronic Navigation, Inc.32719%
Elekta Instrument Ab30918%
Pmt Corporation26615%
Fhc, Inc.1569%
Elekta Solutions Ab1448%
Koh Young Technology Inc.976%
Clearpoint Neuro, Inc.513%
Inomed Medizintechnik Gmbh493%

Top labelers

CompanyDevicesShare
Medtronic Navigation, Inc.32719%
Elekta Instrument Ab30918%
Pmt Corporation26615%
Fhc, Inc.1569%
Elekta Solutions Ab1448%
Koh Young Technology Inc.976%
Clearpoint Neuro, Inc.513%
Inomed Medizintechnik Gmbh493%
Monteris Medical Inc493%
Claronav Kolahi Inc463%
Alpha Omega Engineering Co. Ltd.402%
Alphatec Spine, Inc.342%

Company = labeler of record on GUDID. 31 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Microscope probeENT Sterilization TrayC-Clamp XLC-Clamp LargeC-Clamp mediumC-Clamp smallBiopsy Sterilization TrayReducing tube 2.2mmCranial Sterilization TrayNaviENT Accessory Kit-BNavient systemNavigated Shunt NeedleUniversal Tracker SuctionUniversal Tracker Stimulation probeUniversal Tracker CusaUniversal Tracker Biopsy

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

FDA product codes

CodeNameDevices
HAWNeurological stereotaxic Instrument882
HAWNeurological Stereotaxic Instrument822
OLOOrthopedic stereotaxic instrument78
HAOINSTRUMENT, SURGICAL, NON-POWERED63
GZLElectrode, Depth58
LLZSystem, image processing, radiological40

GMDN & GCC registration

  • GMDN code 32568 · non‑implantable
  • Single‑use 20% · sterile 13% · Rx‑only 96% · 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) · 188Lumen/Inner Diameter (Millimeter) · 72Outer Diameter (Millimeter) · 62Length (Centimeter) · 4Length (Inch) · 2Length (Feet) · 1

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

How many neurological stereotactic surgery system products are registered in the US?

1,744 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Neurological stereotactic surgery system", from 31 companies. The largest labeler is Medtronic Navigation, Inc. with 19% of records.

Which FDA product codes apply?

HAW (Neurological stereotaxic Instrument), HAW (Neurological Stereotaxic Instrument), OLO (Orthopedic stereotaxic instrument), HAO (INSTRUMENT, SURGICAL, NON-POWERED)

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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