Boston Brace Intl., Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Boston Brace Intl., Inc. makes
Boston Brace International, Inc. manufactures static cranioplasty orthoses and cranial remodelling devices, including the Boston Band and Boston-Band Cranial Remodelling Orthosis. These products are designed for cranial reshaping and support in pediatric and adult patients.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) clearance registry. The manufacturer is based in the United States.
Catalogue
Static Cranioplasty Orthosis Ref K063098
510(k) 510(k)Boston Band Ref K111609
510(k) 510(k)Boston-Band Cranial Remodling Orthosis Ref K072862
510(k) 510(k)
Frequently asked questions
How many devices does Boston Brace Intl., Inc. have in the registry?
The registry currently lists 3 devices for Boston Brace Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Boston Brace Intl., Inc.'s devices?
Among its 3 most recently registered devices, Boston Brace Intl., Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Boston Brace Intl., Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Boston Brace Intl., Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Boston Brace Intl., Inc. in the registry?
The most recently registered devices listed for Boston Brace Intl., Inc. include STATIC CRANIOPLASTY ORTHOSIS, BOSTON BAND and BOSTON-BAND CRANIAL REMODLING ORTHOSIS.