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510(k) Data Aggregation
K Number
K070694Device Name
CCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)
Manufacturer
Date Cleared
2007-09-10
(181 days)
Product Code
Regulation Number
882.5970Why did this record match?
Applicant Name (Manufacturer) :
MIKE MINER
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Craniocephalic Custom Remolding Orthosis (CCRO), is indicated for infants 3 - 18 months old to improve cranial symmetry in moderate to severe nonsynostotic positional plagiocephaly, including plagiocephalic, braciocepahlic, and scaphocephalic heads.
Device Description
The CCRO is a passive cranial orthosis that allows an infants cranium to improve in symmetry and/or shape during natural infant growth. Appropriate for infants 3 to 18 months, the CCRO consists of a polypropylene (or copolymer, or polyethylene as warranted), outer shell with multiple inner polypropylene foam liners of various thicknesses, and an optional support strap. The foam liners and outer plastic shell, are vacuum formed over a positive mold developed from an impression of the infant's head. The orthosis allows applicable areas for the infant heads fill in during normal infant growth, to achieve appropriate cranial symmetry.
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