Search Results
Found 1 results
510(k) Data Aggregation
K Number
K063133Device Name
CRANIAL SOLUTION ORTHOSIS
Manufacturer
Date Cleared
2007-07-02
(262 days)
Product Code
Regulation Number
882.5970Why did this record match?
Applicant Name (Manufacturer) :
CRANIAL SOLUTIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Cranial Solutions Orthosis is intended for use on infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly,including infants with plagiocephalic, brachycephalic, and scaphocephalic shaped heads. The CSO is intended to apply gentle pressure to prominent regions of the infant's cranium, and to provide realignment space for depressed cranial regions to improve cranial symmetry and or shape.
Device Description
The CSO is a custom made medical device intended to apply gentle pressure to prominent regions of the infant's cranium, and to provide realignment space for depressed cranial regions to improve symmetry and or shape. The device is of thermoplastic construct. A semi-rigid outer shell of Orthopedic grade copolymer polypropylene thermobonded to a medium durometer polyethylene foam inner liner(Volara). The formula for the outer shell is [ch(ch3)ch2-] 90% polypropylene and 10% polyethylene. By design the CSO is a dynamic orthotic device.
Ask a Question
Ask a specific question about this device
Page 1 of 1