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Device Explorer · FDA GUDID · GMDN 45199

Multi-purpose stereotactic surgery system

An electrically-powered 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 a surgi

US‑registered devices1,264in commercial distribution
Companies13labelers on GUDID
Single‑use6%of device records
Sterile5%labelled sterile
Prescription82%Rx‑only share
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Share of device records

Medtronic Navigation, Inc.89371%
Medtech15412%
Augmedics Ltd1038%
Fiagon Gmbh312%
Stryker Leibinger Gmbh & Co. Kg272%
Philips Ultrasound Llc161%
Mazor Robotics Ltd151%
Surgalign Spine Technologies, Inc.101%

Top labelers

CompanyDevicesShare
Medtronic Navigation, Inc.89371%
Medtech15412%
Augmedics Ltd1038%
Fiagon Gmbh312%
Stryker Leibinger Gmbh & Co. Kg272%
Philips Ultrasound Llc161%
Mazor Robotics Ltd151%
Surgalign Spine Technologies, Inc.101%
Globus Medical, Inc.50%
Medtronic Sofamor Danek, Inc.40%
Acclarent, Inc.40%
Med-Surgical Services, Inc.10%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAMazor X Navigation CameraMazor X SystemDisplayPort to HDMI AdaptorX2 Headset Battery SMALLX2 Headset Battery LARGEX2 Accessories KitX2 HeadsetPC MouseStandard perc pin tray, instruments includedStandard xvision tray, instruments includedPerc Pin AdaptorTall Straight ClampArc ClampStraight ClampXVS C L-Headset IPD-68 Clear Display

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 Instrument623
OLOOrthopedic stereotaxic instrument305
HAWNeurological Stereotaxic Instrument189
OLOOrthopedic Stereotaxic Instrument163
SBFOrthopedic Augmented Reality100
PGWEar, Nose, And Throat Stereotaxic Instrument51

GMDN & GCC registration

  • GMDN code 45199 · non‑implantable
  • Single‑use 6% · sterile 5% · Rx‑only 82% · 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) · 12Weight (Kilogram) · 12Height (Millimeter) · 6Width (Millimeter) · 6Circumference (Inch) · 6Length (Inch) · 5

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

How many multi-purpose stereotactic surgery system products are registered in the US?

1,264 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Multi-purpose stereotactic surgery system", from 13 companies. The largest labeler is Medtronic Navigation, Inc. with 71% of records.

Which FDA product codes apply?

HAW (Neurological stereotaxic Instrument), OLO (Orthopedic stereotaxic instrument), HAW (Neurological Stereotaxic Instrument), OLO (Orthopedic Stereotaxic Instrument)

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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