A collection of mostly instruments intended to be used to manipulate and prepare soft-tissue and bone for the adjustment or placement of the implantable components of an external orthopaedic fixation system in various skeletal areas (e.g., bones of limbs, spin
| Company | Devices | Share |
|---|---|---|
| Gpc Medical Limited | 380 | 76% |
| Zavation Llc | 25 | 5% |
| Cochlear Bone Anchored Solutions Ab | 21 | 4% |
| Toby Orthopaedics | 11 | 2% |
| Gexfix Sa | 11 | 2% |
| Neuropro Spinal Jaxx Inc. | 10 | 2% |
| Ambler Surgical Corp. | 9 | 2% |
| Fusion Orthopedics, Llc | 8 | 2% |
| Biomet Spine Llc | 5 | 1% |
| Osteocentric Technologies, Inc. | 5 | 1% |
| Advanced Orthopaedic Solutions, Inc. | 3 | 1% |
| Captiva Spine, Inc. | 3 | 1% |
Company = labeler of record on GUDID. 15 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 |
|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | 398 |
| FZE | PROSTHESIS, NOSE, INTERNAL | 13 |
| GAD | RETRACTOR | 12 |
| FZX | Guide, Surgical, Instrument | 11 |
| LXB | Hearing aid, bone conduction | 11 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple | 11 |
Use these as the dimensions to specify in a tender line.
497 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General external orthopaedic fixation system implantation kit, reusable", from 15 companies. The largest labeler is Gpc Medical Limited with 76% of records.
LXH (Orthopedic Manual Surgical Instrument), FZE (PROSTHESIS, NOSE, INTERNAL), GAD (RETRACTOR), FZX (Guide, Surgical, 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.