A collection of small sheets of firm material and bone screws, of various shapes/sizes, that are implanted onto fractured craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize the fracture gap, and shield the site from stress as the
| Company | Devices | Share |
|---|---|---|
| Osteomed Llc | 98 | 73% |
| Materialise Nv | 21 | 16% |
| Jeil Medical Corporation | 15 | 11% |
Company = labeler of record on GUDID. 3 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 |
|---|---|---|
| JEY | PLATE, BONE | 47 |
| HWC | Screw, fixation, bone | 40 |
| JEY | Plate, Bone | 21 |
| FSM | Tray, Surgical, Instrument | 13 |
| DZL | SCREW, FIXATION, INTRAOSSEOUS | 6 |
| HRS | Plate, fixation, bone | 4 |
Use these as the dimensions to specify in a tender line.
134 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Craniofacial fixation plate kit, non-bioabsorbable", from 3 companies. The largest labeler is Osteomed Llc with 73% of records.
JEY (PLATE, BONE), HWC (Screw, fixation, bone), JEY (Plate, Bone), FSM (Tray, 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.