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Device Explorer · FDA GUDID · GMDN 61407

Optical surgical tracking system spatial marker, reusable

A non-powered, noninvasive component of a surgical navigation and/or tracking system (e.g., computer-assisted surgical ultrasound system, surgical microscope) intended for preoperative and/or intraoperative use to function as an optical reference to enable spa

US‑registered devices55in commercial distribution
Companies8labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Kico Knee Innovation Company Pty Limited2545%
Ecential Robotics1120%
Exactech, Inc.59%
Medos International Sàrl59%
Proprio, Inc.47%
Karl Storz Gmbh & Co. Kg35%
Stryker Leibinger Gmbh & Co. Kg12%
Brainlab Se12%

Top labelers

CompanyDevicesShare
Kico Knee Innovation Company Pty Limited2545%
Ecential Robotics1120%
Exactech, Inc.59%
Medos International Sàrl59%
Proprio, Inc.47%
Karl Storz Gmbh & Co. Kg35%
Stryker Leibinger Gmbh & Co. Kg12%
Brainlab Se12%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

N/APATIENT REFERENCE ARRAY SPINE & TRAUMAn.a.Op.n™ Tracker DOp.n™ Tracker COp.n™ Tracker BOp.n™ Tracker AOp.n™ ST Burr AdapterOp.n™ Patient TrackerOp.n™ CoBot Tool Holder TrackerOp.n Tracker DOp.n Tracker COp.n Tracker BOp.n Tracker AParadigmARVIS ®

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

FDA product codes

CodeNameDevices
OLOOrthopedic Stereotaxic Instrument40
OLOOrthopedic stereotaxic instrument6
HAWNeurological Stereotaxic Instrument5
PGWEar, Nose, and Throat Stereotaxic Instrument2
SBFOrthopedic Augmented Reality2
HAWNeurological stereotaxic Instrument1

GMDN & GCC registration

  • GMDN code 61407 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 93% · 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

No structured size data on the register.

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

How many optical surgical tracking system spatial marker, reusable products are registered in the US?

55 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Optical surgical tracking system spatial marker, reusable", from 8 companies. The largest labeler is Kico Knee Innovation Company Pty Limited with 45% of records.

Which FDA product codes apply?

OLO (Orthopedic Stereotaxic Instrument), OLO (Orthopedic stereotaxic instrument), HAW (Neurological Stereotaxic Instrument), PGW (Ear, Nose, and Throat 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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