A custom-made helmet-like device intended to be worn on the head of an infant with an abnormal head shape (e.g., due to plagiocephaly, brachycephaly, scaphocephaly), or after craniosynostosis repair surgery, to apply pressure to the cranium and improve cranial
| Company | Devices | Share |
|---|---|---|
| Orthomerica Products, Inc. | 125 | 79% |
| Invent Medical Usa Llc | 12 | 8% |
| Otto Bock Healthcare | 10 | 6% |
| Cranial Technologies, Inc. | 2 | 1% |
| Symbiont Logistics, Llc | 2 | 1% |
| Biosculptor Corporation | 1 | 1% |
| Danmar Products Inc | 1 | 1% |
| Boston Brace International, Inc. | 1 | 1% |
| Surestep, Llc | 1 | 1% |
| Hanger Natrional Laboratories Llc | 1 | 1% |
| Ppod Orthotics Inc. | 1 | 1% |
| Vorum Research Corporation | 1 | 1% |
Company = labeler of record on GUDID. 12 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 |
|---|---|---|
| MVA | Orthosis, Cranial | 158 |
| OAN | Orthosis, Cranial, Laser Scan | 131 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
158 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cranial orthosis", from 12 companies. The largest labeler is Orthomerica Products, Inc. with 79% of records.
MVA (Orthosis, Cranial), OAN (Orthosis, Cranial, Laser Scan)
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.
Add cranial orthosis to the RFQ basket or use the form below with quantity, specification and delivery location; the Network returns comparable quotes from verified suppliers in 2–5 working days.
Hospitals, pharmacies and distributors anywhere: tell us what you need and the Consulting Wallah Network returns comparable quotes from verified suppliers. No fee for buyers.
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.