510(k) K072862
K072862 is an FDA 510(k) premarket notification submitted by Boston Brace Intl., Inc. for the device "BOSTON-BAND CRANIAL REMODLING ORTHOSIS". The FDA issued a decision of Substantially Equivalent on January 22, 2008. The device falls under product code OAN (Orthosis, Cranial, Laser Scan), a Class II device regulated under 21 CFR 882.5970. Boston Brace Intl., Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 2008
- Date Received
- October 5, 2007
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Cranial, Laser Scan
- Device Class
- Class II
- Regulation Number
- 882.5970
- Review Panel
- NE
- Submission Type
A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. A laser scanning accessory may be used to create a scan of the infant's head. Indicated for infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.