MVA
- Product code
- MVA
- Device name
- Orthosis, Cranial
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5970
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 43
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K241957 | 2024-08-30 | Invent Medical USA, LLC | Talee, Talee PostOp |
Official FDA classification page: MVA
Classification and pathway per current FDA publications. Data from openFDA (CC0).