A mobile assembly of mains electricity (AC-powered) devices intended for both pre- and intraoperative applications to: 1) process medical imaging data to create a patient-specific, three-dimensional (3-D) model to enable a surgeon to plan/prepare for a surgica
| Company | Devices | Share |
|---|---|---|
| Xnav Technologies Llc | 132 | 56% |
| Stryker Leibinger Gmbh & Co. Kg | 26 | 11% |
| Claronav Inc | 22 | 9% |
| Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 16 | 7% |
| Smith & Nephew, Inc. | 9 | 4% |
| Surgical Theater Llc | 7 | 3% |
| Intuitive Surgical, Inc. | 5 | 2% |
| Novarad Corporation | 5 | 2% |
| Circinus Medical Technology Llc | 4 | 2% |
| Therenva | 3 | 1% |
| Navigate Surgical Technologies Inc | 2 | 1% |
| Stryker Corporation | 1 | 0% |
Company = labeler of record on GUDID. 16 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 |
|---|---|---|
| PLV | Dental Stereotaxic Instrument | 145 |
| QRY | Dental Navigation System | 59 |
| DZL | Screw, Fixation, Intraosseous | 20 |
| SBF | Orthopedic Augmented Reality | 15 |
| LLZ | System, Image Processing, Radiological | 15 |
| HAW | Neurological stereotaxic Instrument | 14 |
Use these as the dimensions to specify in a tender line.
236 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical planning/navigation-enhancement system", from 16 companies. The largest labeler is Xnav Technologies Llc with 56% of records.
PLV (Dental Stereotaxic Instrument), QRY (Dental Navigation System), DZL (Screw, Fixation, Intraosseous), SBF (Orthopedic Augmented Reality)
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.