MVAClass II

Orthosis, Cranial

21 CFR 882.5970 / Neurology

MVA is the FDA product code for Orthosis, Cranial, a class II device type, regulated under 21 CFR 882.5970. As of 2026-09-10, FDA records hold 43 510(k) clearances under this code, the most recent dated 2024-08-30, and no recalls.

Classification record

Product code: MVA
Device name: Orthosis, Cranial
Regulation: 21 CFR 882.5970
Device class: Class II
Review panel: Neurology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 43
Ingested recalls: 0

Clearances, product code MVA

By decision year

43 clearances under product code MVA with a decision year between 1998 and 2024, 2001 the highest year at 8.

Show the numbers

510(k) clearances under FDA product code MVA by decision year
Year	Clearances
1998	1
2000	3
2001	8
2002	6
2003	4
2004	2
2006	1
2007	2
2010	1
2011	3
2014	3
2018	1
2021	2
2022	3
2023	2
2024	1

Applicants with the most clearances

Product code MVA

Applicants holding the most 510(k) clearances under product code MVA
Applicant	Clearances
Orthomerica Products, Inc.	4
Danmar Products, Inc.	3
Invent Medical USA, LLC	3
Otto Bock Healthcare LP	3
Cranial Technologies, Inc.	2
Eastern Cranial Affiliates	2
Orthotic & Prosthetic Lab, Inc.	2
Advanced Orthopro, Inc.	1
Becker Orthopedic Appliance Co.	1
Beverly Hills Prosthetics Orthotics, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order