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Device Explorer · FDA GUDID · GMDN 61410

Optical surgical tracking system spatial marker connector

A component of a surgical navigation and/or tracking system (e.g., optical/electromagnetic device tracking system, computer-assisted neurosurgical ultrasound navigation system) intended to connect the system’s spatial marker [localizer/tracker/calibrator (e.g.

US‑registered devices71in commercial distribution
Companies10labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription86%Rx‑only share
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Share of device records

7D Surgical Ulc3854%
Ecential Robotics913%
Medos International Sàrl913%
Stryker Leibinger Gmbh & Co. Kg46%
Scopis Gmbh46%
Vb Spine Llc34%
Brainlab Se11%
Proprio, Inc.11%

Top labelers

CompanyDevicesShare
7D Surgical Ulc3854%
Ecential Robotics913%
Medos International Sàrl913%
Stryker Leibinger Gmbh & Co. Kg46%
Scopis Gmbh46%
Vb Spine Llc34%
Brainlab Se11%
Proprio, Inc.11%
Depuy Spine, Llc11%
Spineart Sa11%

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

Brand names on the register (sample)

n/aGauge for Softouch Registration PointerQuick release holder, L-column 450x100mmOp.n™ Instrument Tracker ConnectorOp.n™ Registration ConnectorOp.n™ Patient Tracker ConnectorOp.n™ Fixation ScrewOp.n Cobot Tool HolderTracker fixation screwCoBot, Tool HolderFixation screwParadigm Drill Guide Trocar7D Surgical Universal Array (6)7D Surgical Universal Array (5)7D Surgical Flex Rod Connector (4.5 mm - 100 mm)7D Surgical Spine Reference Clamp (Multi-Level)

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 Instrument45
OLOOrthopedic stereotaxic instrument13
HAWNeurological Stereotaxic Instrument6
HAWNeurological stereotaxic Instrument4
PGWEar, Nose, and Throat Stereotaxic Instrument4
PGWEar, Nose, And Throat Stereotaxic Instrument4

GMDN & GCC registration

  • GMDN code 61410 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 86% · 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 connector products are registered in the US?

71 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 connector", from 10 companies. The largest labeler is 7D Surgical Ulc with 54% of records.

Which FDA product codes apply?

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