Data / Medical devices / Orthosis, Cranial
Orthosis, Cranial (MVA): 14 FDA-registered makers in 2 countries
14 establishments in 2 countries are registered with the FDA to make Orthosis, Cranial (product code MVA, Class 2, 21 CFR 882.5970). 11 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 43 510(k) clearances under this code, the latest on August 30, 2024, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MVA
- Device class
- 2
- Regulation
- 882.5970
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
| Canada | 1 |
Makers of Orthosis, Cranial
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Danmar Products, Inc. | Ann Arbor, MI, United States | Manufacturer | 3 | January 6, 2010 | 0 | 0 | 0 | api.fda.gov |
| Invent Medical Usa, LLC | Loveland, CO, United States | Manufacturer | 3 | August 30, 2024 | 0 | 0 | 0 | api.fda.gov |
| Invent Medical Usa, LLC | Warminster, PA, United States | Manufacturer | 3 | August 30, 2024 | 0 | 0 | 0 | api.fda.gov |
| Orthomerica Products, Inc. | Orlando, FL, United States | Manufacturer, Specification developer | 3 | April 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Cranial Technologies, Inc. | Chandler, AZ, United States | Manufacturer | 2 | December 17, 2004 | 0 | 0 | 0 | api.fda.gov |
| Otto Bock Healthcare LP | Salt Lake City, UT, United States | Manufacturer | 2 | June 9, 2022 | 0 | 0 | 0 | api.fda.gov |
| Symbiont Logistics, LLC | Phoenix, AZ, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 2 | July 1, 2022 | 0 | 0 | 0 | api.fda.gov |
| Boston Brace International, Incorporated | Stoughton, MA, United States | Complaint file establishment, Manufacturer | 1 | August 22, 2011 | 0 | 0 | 0 | api.fda.gov |
| Eastern Cranial Affiliates | Fairfax, VA, United States | Manufacturer | 1 | October 16, 2018 | 0 | 0 | 0 | api.fda.gov |
| Headstart Medical | New Westminster British Columbia, Canada | Manufacturer | 1 | June 7, 2021 | 0 | 0 | 0 | api.fda.gov |
| Personal Performance Medical Corp. | Midvale, UT, United States | Manufacturer | 1 | January 17, 2002 | 0 | 0 | 0 | api.fda.gov |
| Abcorp | Boston, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abcorp 3D | Columbia, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biosculptor Corporation | Hialeah, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 30, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.