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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthosis, cranial, laser scan
Definition 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.
Product CodeOAN
Regulation Number 882.5970
Device Class 2


Premarket Reviews
ManufacturerDecision
ORTHOMERICA PRODUCTS INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hematoma 1 1
Skull Fracture 1 1

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