A software program intended to add specific computer-assisted display, processing, and/or analysis capabilities to prepare for the implantation of an orthopaedic and/or craniomaxillofacial (CMF) prosthesis. Using digitized x-rays or imported computed tomograph
| Company | Devices | Share |
|---|---|---|
| Meridian Technique Limited | 49 | 44% |
| Medacta International Sa | 26 | 23% |
| Biomet Orthopedics, Llc | 7 | 6% |
| Smith & Nephew, Inc. | 6 | 5% |
| Peek Health, S.A. | 2 | 2% |
| Medicad Hectec Gmbh | 2 | 2% |
| Onefit Medical | 2 | 2% |
| Fournitures Hospitalieres Industrie | 2 | 2% |
| Alphatec Spine, Inc. | 2 | 2% |
| Materialise Nv | 1 | 1% |
| Avatar Medical | 1 | 1% |
| Eos Imaging | 1 | 1% |
Company = labeler of record on GUDID. 22 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 |
|---|---|---|
| LLZ | System, Image Processing, Radiological | 90 |
| PBF | Orthopaedic Surgical Planning And Instrument Guides | 14 |
| LLZ | System, image processing, radiological | 10 |
| PBF | Orthopaedic surgical planning and instrument guides | 5 |
| QIH | Automated Radiological Image Processing Software | 3 |
| QHE | Shoulder Arthroplasty Implantation System | 2 |
Use these as the dimensions to specify in a tender line.
111 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic/craniofacial implantation planning software", from 22 companies. The largest labeler is Meridian Technique Limited with 44% of records.
LLZ (System, Image Processing, Radiological), PBF (Orthopaedic Surgical Planning And Instrument Guides), LLZ (System, image processing, radiological), PBF (Orthopaedic surgical planning and instrument guides)
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.