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Device Explorer · FDA GUDID · GMDN 45169

Stereotactic surgery system probe, reusable

A slender, rod-like, hand-held manual surgical instrument intended for use during image-guided surgery (e.g., neurosurgical or orthopaedic surgery procedures) to accurately position implantable devices (e.g., shunts), or to correlate the position of its tip wi

US‑registered devices766in commercial distribution
Companies24labelers on GUDID
Single‑use5%of device records
Sterile1%labelled sterile
Prescription47%Rx‑only share
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Share of device records

Mazor Robotics Ltd40853%
Medtronic Navigation, Inc.13117%
Medos International Sàrl415%
Spinecraft, Llc375%
7D Surgical Ulc334%
Smith & Nephew, Inc.304%
Stryker Leibinger Gmbh & Co. Kg284%
Curiteva, Inc.111%

Top labelers

CompanyDevicesShare
Mazor Robotics Ltd40853%
Medtronic Navigation, Inc.13117%
Medos International Sàrl415%
Spinecraft, Llc375%
7D Surgical Ulc334%
Smith & Nephew, Inc.304%
Stryker Leibinger Gmbh & Co. Kg284%
Curiteva, Inc.111%
Spineology Inc.91%
Mako Surgical Corp.81%
Karl Storz Gmbh & Co. Kg71%
Zavation Llc61%

Company = labeler of record on GUDID. 24 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

INSTRUMENTBlack ProbeN/An/aUniversal ScrewdriverSA 4.0mm Schanz screwMazor X Guidewire Instruments SetSchanz screw 4mmx150mm, 10 packSchanz Screw 4x80mm, 10 pack w/o CESchanz Screw 4x120mm, 10 pack w/o CEHead Pin 2.5x100mm, 10 pack w/o CEHead Pin 2.5x60mm, 10 pack w/o CEShort Drill 3x80mm, 10 packShort Drill 3x30mm, 10 packLong Drill 3x30mm, 10 packLong drill 3x80mm,10 pack

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

FDA product codes

CodeNameDevices
LLZSystem, Image Processing, Radiological449
OLOOrthopedic Stereotaxic Instrument328
HAWNeurological Stereotaxic Instrument213
OLOOrthopedic stereotaxic instrument155
HAWNeurological stereotaxic Instrument107
NBHACCESSORIES,ARTHROSCOPIC54

GMDN & GCC registration

  • GMDN code 45169 · non‑implantable
  • Single‑use 5% · sterile 1% · Rx‑only 47% · 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

Width (Millimeter) · 6Outer Diameter (Millimeter) · 5Length (Centimeter) · 1Length (Inch) · 1

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

How many stereotactic surgery system probe, reusable products are registered in the US?

766 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Stereotactic surgery system probe, reusable", from 24 companies. The largest labeler is Mazor Robotics Ltd with 53% of records.

Which FDA product codes apply?

LLZ (System, Image Processing, Radiological), 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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