A small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, cover a burr hole and/or position/stabilize
| Company | Devices | Share |
|---|---|---|
| Kls-Martin L.P. | 1,314 | 16% |
| Biomet Microfixation, Inc | 1,278 | 16% |
| Stryker Leibinger Gmbh & Co. Kg | 1,048 | 13% |
| Osteomed Llc | 878 | 11% |
| Synthes Gmbh | 793 | 10% |
| Jeil Medical Corporation | 541 | 7% |
| Medicon Eg. Chirurgiemechaniker-Genossenschaft | 471 | 6% |
| Bioplate, Inc. | 439 | 5% |
| Visionare, Llc | 421 | 5% |
| Neoortho Produtos Ortopédicos S/A. | 165 | 2% |
| Biomaterials Korea, Inc. | 132 | 2% |
| Medcad | 130 | 2% |
Company = labeler of record on GUDID. 29 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 | 5,287 |
| JEY | Plate, Bone | 2,635 |
| GWO | Plate, cranioplasty, preformed, alterable | 733 |
| DZL | SCREW, FIXATION, INTRAOSSEOUS | 671 |
| GXR | COVER, BURR HOLE | 625 |
| HBW | FASTENER, PLATE, CRANIOPLASTY | 509 |
Use these as the dimensions to specify in a tender line.
8,019 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Craniofacial fixation plate, non-bioabsorbable, non-customized", from 29 companies. The largest labeler is Kls-Martin L.P. with 16% of records.
JEY (PLATE, BONE), JEY (Plate, Bone), GWO (Plate, cranioplasty, preformed, alterable), DZL (SCREW, FIXATION, INTRAOSSEOUS)
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.