An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material (e.g., tantalum) that can be reshaped at the time of surgery without changing the physical or chemical properties of the mat
| Company | Devices | Share |
|---|---|---|
| Jeil Medical Corporation | 44 | 33% |
| Inno Holdings, Inc. | 42 | 31% |
| Biomet Microfixation, Inc | 17 | 13% |
| Kinamed, Inc. | 15 | 11% |
| Osteomed Llc | 13 | 10% |
| Neurovention Llc | 4 | 3% |
Company = labeler of record on GUDID. 6 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 |
|---|---|---|
| GWO | Plate, Cranioplasty, Preformed, Alterable | 190 |
| GWO | Plate, cranioplasty, preformed, alterable | 69 |
| GXR | COVER, BURR HOLE | 65 |
| GXR | Cover, Burr Hole | 65 |
| HBW | FASTENER, PLATE, CRANIOPLASTY | 60 |
| HBW | Fastener, Plate, Cranioplasty | 51 |
Use these as the dimensions to specify in a tender line.
135 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cranioplasty plate, alterable", from 6 companies. The largest labeler is Jeil Medical Corporation with 33% of records.
GWO (Plate, Cranioplasty, Preformed, Alterable), GWO (Plate, cranioplasty, preformed, alterable), GXR (COVER, BURR HOLE), GXR (Cover, Burr Hole)
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.