FDA product code MVA: Orthosis, Cranial
MVA is the FDA product code for orthosis, cranial. It is a Class II device, regulated under 21 CFR 882.5970 and reviewed by the Neurology panel. FDA has cleared 42 510(k) submissions under MVA, 6 in the last five years, from 32 different applicants. The average 510(k) review took 180 days (median 122); 58 days on average over the last three years. 1 De Novo request was granted under it.
Classification
| Field | Value |
|---|---|
| Device name | Orthosis, Cranial |
| Device class | Class II |
| Regulation | 21 CFR 882.5970 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for MVA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 225 |
| 2021 | 2 | 426 |
| 2022 | 3 | 342 |
| 2023 | 2 | 152 |
| 2024 | 1 | 58 |
Compare with all 510(k) review times · Search every MVA clearance
Top MVA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Orthomerica Products, Inc. | 4 | 2023-04-20 |
| Invent Medical USA, LLC | 3 | 2024-08-30 |
| Otto Bock Healthcare LP | 3 | 2022-06-09 |
| Danmar Products, Inc. | 3 | 2010-01-06 |
| Orthotic & Prosthetic Lab, Inc. | 2 | 2006-12-22 |
27 more applicants have MVA clearances. See the full list in Caduvo.
Most recent MVA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241957 | Invent Medical USA, LLC | Talee, Talee PostOp | 2024-08-30 | 58 |
| K230444 | Invent Medical USA, LLC | Talee, Talee PostOp | 2023-06-22 | 121 |
| K223238 | Orthomerica Products, Inc. | STARband 3D | 2023-04-20 | 182 |
| K220681 | Invent Medical USA, LLC | Talee, Talee PostOP | 2022-09-22 | 198 |
| K203134 | Symbion Logistics, LLC | Hanger Cranial Band 3D | 2022-07-01 | 620 |
Recalls for MVA devices
openFDA lists no recalls for product code MVA.
Frequently asked questions
What is FDA product code MVA?
MVA is the FDA product code for orthosis, cranial. It is a Class II device, regulated under 21 CFR 882.5970 and reviewed by the Neurology panel.
What device class is MVA?
Class II, regulation 21 CFR 882.5970. Typical premarket route: 510(k).
How long does a 510(k) take for product code MVA?
Across 42 cleared submissions the average was 180 days from receipt to decision (median 122).
Which companies have the most MVA clearances?
Orthomerica Products, Inc. (4); Invent Medical USA, LLC (3); Otto Bock Healthcare LP (3); Danmar Products, Inc. (3); Orthotic & Prosthetic Lab, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code MVA
- Run a recall and safety report across every MVA manufacturer
- Watch product code MVA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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