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, and/or cover a burr hole. It is made of bioa
| Company | Devices | Share |
|---|---|---|
| Kls-Martin L.P. | 133 | 38% |
| Stryker Leibinger Gmbh & Co. Kg | 83 | 24% |
| Synthes Gmbh | 67 | 19% |
| Biomet Microfixation, Inc | 65 | 19% |
| Aesculap Ag | 2 | 1% |
Company = labeler of record on GUDID. 5 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 | 248 |
| HBW | FASTENER, PLATE, CRANIOPLASTY | 116 |
| GXR | COVER, BURR HOLE | 74 |
| HRS | PLATE, FIXATION, BONE | 53 |
| HWC | Screw, fixation, bone | 51 |
| GWO | Plate, cranioplasty, preformed, alterable | 45 |
Use these as the dimensions to specify in a tender line.
350 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Craniofacial fixation plate, bioabsorbable", from 5 companies. The largest labeler is Kls-Martin L.P. with 38% of records.
JEY (PLATE, BONE), HBW (FASTENER, PLATE, CRANIOPLASTY), GXR (COVER, BURR HOLE), HRS (PLATE, FIXATION, BONE)
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.