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Device Explorer · FDA GUDID · GMDN 45200

Orthopaedic 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 orthopaedic surgery. The sys

US‑registered devices719in commercial distribution
Companies23labelers on GUDID
Single‑use13%of device records
Sterile9%labelled sterile
Prescription92%Rx‑only share
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Share of device records

Nuvasive, Inc.13318%
Intellijoint Surgical Inc8312%
Point Robotics Medtech Inc.7911%
Medtronic Navigation, Inc.6910%
Kico Knee Innovation Company Pty Limited618%
Exactech, Inc.548%
Smith & Nephew, Inc.385%
Onpoint Surgical, Inc.385%

Top labelers

CompanyDevicesShare
Nuvasive, Inc.13318%
Intellijoint Surgical Inc8312%
Point Robotics Medtech Inc.7911%
Medtronic Navigation, Inc.6910%
Kico Knee Innovation Company Pty Limited618%
Exactech, Inc.548%
Smith & Nephew, Inc.385%
Onpoint Surgical, Inc.385%
Intai Technology Corp.355%
Ulrich Medical Usa, Inc.314%
Orthalign, Inc.264%
Medtronic Sofamor Danek, Inc.243%

Company = labeler of record on GUDID. 23 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

WatchTower ROAMWatchTowerPOINT ROBOTICS MEDTECH INC.WatchTower Navi Disposable InstrumentKneePlusPortalTRIGENACHIEVECASiASSISTiASSIST®NuVasivePULSENATrigenSURESHOTN/A

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 Instrument314
OLOOrthopedic stereotaxic instrument270
HAWNeurological stereotaxic Instrument235
LLZSystem, image processing, radiological115
GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE109
PDQNeurosurgical nerve locator107

GMDN & GCC registration

  • GMDN code 45200 · non‑implantable
  • Single‑use 13% · sterile 9% · Rx‑only 92% · 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) · 11Length (Millimeter) · 8Length (Inch) · 6Angle (degree) · 3Outer Diameter (Millimeter) · 2

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

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

719 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic stereotactic surgery system", from 23 companies. The largest labeler is Nuvasive, Inc. with 18% of records.

Which FDA product codes apply?

OLO (Orthopedic Stereotaxic Instrument), OLO (Orthopedic stereotaxic instrument), HAW (Neurological stereotaxic Instrument), LLZ (System, image processing, radiological)

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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