A flat piece of implantable metal (typically tantalum) designed to repair small cranial bone defects (i.e., cranioplasty). It is usually perforated and can be shaped to a desired contour using a mallet and a wood block and cut with shears to an appropriate dim
| Company | Devices | Share |
|---|---|---|
| Biomet Microfixation, Inc | 48 | 79% |
| Kinamed, Inc. | 13 | 21% |
Company = labeler of record on GUDID. 2 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 | 69 |
| GWO | Plate, cranioplasty, preformed, alterable | 66 |
| GXR | COVER, BURR HOLE | 48 |
| HBW | FASTENER, PLATE, CRANIOPLASTY | 48 |
| HBW | Fastener, Plate, Cranioplasty | 13 |
| GXR | Cover, Burr Hole | 13 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
61 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cranioplasty sheet", from 2 companies. The largest labeler is Biomet Microfixation, Inc with 79% of records.
JEY (PLATE, BONE), GWO (Plate, cranioplasty, preformed, alterable), GXR (COVER, BURR HOLE), HBW (FASTENER, PLATE, CRANIOPLASTY)
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.