Consulting Wallah › Device Explorer › Other devices › Optical surgical navigation/tracking system
Device Explorer · FDA GUDID · GMDN 62782

Optical surgical navigation/tracking system

A mobile assembly of electrically-powered devices intended to provide a physician with optical tools to track manual surgical instruments and locate anatomical structures; it may be intended to overlay pre-acquired radiological images or real-time data [e.g.,

US‑registered devices438in commercial distribution
Companies10labelers on GUDID
Single‑use20%of device records
Sterile20%labelled sterile
Prescription83%Rx‑only share
ShareLinkedIn

Share of device records

Medacta International Sa28164%
Stryker Leibinger Gmbh & Co. Kg6014%
Naviswiss Ag5412%
Pathkeeper Surgical Ltd235%
Depuy (Ireland)82%
Surgalign Spine Technologies, Inc.72%
Ecential Robotics20%
Smith & Nephew, Inc.10%

Top labelers

CompanyDevicesShare
Medacta International Sa28164%
Stryker Leibinger Gmbh & Co. Kg6014%
Naviswiss Ag5412%
Pathkeeper Surgical Ltd235%
Depuy (Ireland)82%
Surgalign Spine Technologies, Inc.72%
Ecential Robotics20%
Smith & Nephew, Inc.10%
Proprio, Inc.10%
7D Surgical Ulc10%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

N/APROFESSSPINEMAPNACranialMask TrackerCRANIALMAPORTHOMAPFLUOROMAPPIGALILEOPKS DRF 3 - ID 12.2PKS DRF 4 - ID 7.9PKS DRF 2 - ID 5.9PKS Patient Reference DRFPathKeeper Surgical Accessories KitPKS DRF 3-ID15PKS DRF 4-ID9.5x8

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

FDA product codes

CodeNameDevices
SBFOrthopedic Augmented Reality257
LXHOrthopedic Manual Surgical Instrument46
OLOOrthopedic stereotaxic instrument43
OLOOrthopedic Stereotaxic Instrument42
HAWNeurological stereotaxic Instrument35
JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cem23

GMDN & GCC registration

  • GMDN code 62782 · non‑implantable
  • Single‑use 20% · sterile 20% · Rx‑only 83% · 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

Height (Millimeter) · 1Width (Millimeter) · 1Length (Millimeter) · 1

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

How many optical surgical navigation/tracking system products are registered in the US?

438 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Optical surgical navigation/tracking system", from 10 companies. The largest labeler is Medacta International Sa with 64% of records.

Which FDA product codes apply?

SBF (Orthopedic Augmented Reality), LXH (Orthopedic Manual Surgical Instrument), OLO (Orthopedic 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.

How do I get quotes?

Add optical surgical navigation/tracking system to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.

Request quotes for Optical surgical navigation/tracking system

Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.

Buying optical surgical navigation/tracking system for a hospital group?Free executive assessment: we benchmark your prices and tender structure against the Network.
Book the free assessment

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.

Get quotes →