An assembly of electromechanical devices designed to be used during computer assisted surgery (CAS) as a functional extension of the surgeon for precise procedural movement and placement (navigation) during the procedure (e.g., placement of a pedicle screw in
| Company | Devices | Share |
|---|---|---|
| Globus Medical, Inc. | 741 | 73% |
| Brainlab Se | 129 | 13% |
| Alphatec Spine, Inc. | 31 | 3% |
| Exactech, Inc. | 25 | 2% |
| Point Robotics Medtech Inc. | 22 | 2% |
| Omni Life Science, Inc. | 16 | 2% |
| Orthosoft Inc | 10 | 1% |
| Mako Surgical Corp. | 8 | 1% |
| Quantum Surgical | 7 | 1% |
| Medos International Sàrl | 7 | 1% |
| Stryker Leibinger Gmbh & Co. Kg | 6 | 1% |
| Stereotaxis, Inc. | 5 | 0% |
Company = labeler of record on GUDID. 21 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| OLO | Orthopedic stereotaxic instrument | 776 |
| OLO | Orthopedic Stereotaxic Instrument | 346 |
| HAW | Neurological Stereotaxic Instrument | 336 |
| HAW | Neurological stereotaxic Instrument | 24 |
| HWE | INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCES | 21 |
| GFF | BUR, SURGICAL, GENERAL & PLASTIC SURGERY | 21 |
Use these as the dimensions to specify in a tender line.
1,022 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Robotic surgical navigation system", from 21 companies. The largest labeler is Globus Medical, Inc. with 73% of records.
OLO (Orthopedic stereotaxic instrument), OLO (Orthopedic Stereotaxic Instrument), HAW (Neurological Stereotaxic Instrument), HAW (Neurological stereotaxic Instrument)
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.