An individual application software program or group of programs, routines and/or algorithms designed for use in association with a robotic surgical navigation system used in computer assisted surgery (CAS) so that this can function according to its intended pu
| Company | Devices | Share |
|---|---|---|
| Kico Knee Innovation Company Pty Limited | 46 | 51% |
| Omni Life Science, Inc. | 15 | 17% |
| Stryker Leibinger Gmbh & Co. Kg | 12 | 13% |
| Mako Surgical Corp. | 7 | 8% |
| Stereotaxis, Inc. | 5 | 6% |
| Smith & Nephew, Inc. | 2 | 2% |
| Orthosoft Inc | 2 | 2% |
| Aspen Surgical Products, Inc. | 1 | 1% |
Company = labeler of record on GUDID. 8 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 | 49 |
| OLO | Orthopedic stereotaxic instrument | 37 |
| HAW | Neurological stereotaxic Instrument | 5 |
| NDQ | System, Catheter Or Guidewire, Steerable (Magnetic) | 5 |
| NFG | DEVICE, COMMUNICATIONS, IMAGES, OPHTHALMIC | 3 |
| PJB | Catheter Remote Control System | 2 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
90 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Robotic surgical navigation system application software", from 8 companies. The largest labeler is Kico Knee Innovation Company Pty Limited with 51% of records.
OLO (Orthopedic Stereotaxic Instrument), OLO (Orthopedic stereotaxic instrument), HAW (Neurological stereotaxic Instrument), NDQ (System, Catheter Or Guidewire, Steerable (Magnetic))
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.