Medical Device Manufacturer · US , Avon , MA

Boston Brace Intl., Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2007

Recent clearances: BOSTON BAND, BOSTON-BAND CRANIAL REMODLING ORTHOSIS, STATIC CRANIOPLASTY ORTHOSIS

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Boston Brace Intl., Inc. Neurology ✕

3 devices

1-3 of 3

Cleared Aug 22, 2011

Neurology · 74d

Cleared Jan 22, 2008

BOSTON-BAND CRANIAL REMODLING ORTHOSIS

Neurology · 109d

Cleared Apr 11, 2007

STATIC CRANIOPLASTY ORTHOSIS

Neurology · 183d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 15, 2026