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MVA — Orthosis, Cranial Class II

FDA Device Classification

Classification Details

Product Code
MVA
Device Class
Class II
Regulation Number
882.5970
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241957invent medical usaTalee, Talee PostOpAugust 30, 2024
K230444invent medical usaTalee, Talee PostOpJune 22, 2023
K223238orthomerica productsSTARband 3DApril 20, 2023
K220681invent medical usaTalee, Talee PostOPSeptember 22, 2022
K203134symbion logisticsHanger Cranial Band 3DJuly 1, 2022
K213587otto bock healthcareMyCRO BandJune 9, 2022
K193383headstartSnugKapJune 7, 2021
K201426otto bock healthcareMyCRO BandMarch 26, 2021
K180568eastern cranial affiliatesKidCapOctober 16, 2018
K141842orthomerica productsSTARBAND, STARLIGHTOctober 6, 2014
K140353orthomerica productsSTARBAND AND STARLIGHTJune 6, 2014
K133397p-podP-PODApril 18, 2014
K111609boston brace intlBOSTON BANDAugust 22, 2011
K111247orthotic care servicesCRANIAL REMOLDING ORTHOSISAugust 15, 2011
K103362advanced orthoproAOI CRANIAL HELMETApril 18, 2011
K090341danmar productsMICHIGAN CRANIAL RESHAPING ORTHOSISJanuary 6, 2010
K070694mike minerCCRO (CRANIOCEPHALIC CUSTOM REMOLDING ORTHOSIS)September 10, 2007
K063133cranial solutionsCRANIAL SOLUTION ORTHOSISJuly 2, 2007
K063395orthotic and prosthetic labO&P BIVALVE CRANIAL MOLDING HELMETDecember 22, 2006
K042385cranial technologiesDOC BAND-POSTOPDecember 17, 2004