An implantable shield designed to repair larger skull defects that is preformed before surgery and typically made of sheets of material [e.g., stainless steel, vitallium, titanium (Ti), plastic resins] that cannot be reshaped at the time of surgery without cha
| Company | Devices | Share |
|---|---|---|
| Biomet Microfixation, Inc | 3,382 | 92% |
| Bioplate, Inc. | 161 | 4% |
| Osteonic Co.,Ltd. | 39 | 1% |
| Medcad | 38 | 1% |
| Stryker Leibinger Gmbh & Co. Kg | 24 | 1% |
| Meticuly Company Limited | 22 | 1% |
| Howmedica Osteonics Corp. | 5 | 0% |
| Kelyniam Global, Inc. | 4 | 0% |
| Osteosymbionics, Llc | 3 | 0% |
| 3D Systems, Inc. | 2 | 0% |
| Kontour(Xi'An) Medical Technology Co.,Ltd. | 1 | 0% |
| Avalign Technologies, Inc. | 1 | 0% |
Company = labeler of record on GUDID. 13 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 |
|---|---|---|
| FWP | Prosthesis, Chin, Internal | 3,383 |
| FZE | Prosthesis, Nose, Internal | 3,383 |
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxil | 3,383 |
| LZK | Implant, Malar | 3,383 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 2,118 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 41 |
Use these as the dimensions to specify in a tender line.
3,683 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cranioplasty plate, non-alterable", from 13 companies. The largest labeler is Biomet Microfixation, Inc with 92% of records.
FWP (Prosthesis, Chin, Internal), FZE (Prosthesis, Nose, Internal), KKY (Material, Polytetrafluoroethylene Vitreous Carbon, For Maxil), LZK (Implant, Malar)
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.