K Number
K961802Device Name
PRECLUDE SYNBLOC MEMBRANEManufacturer
Date Cleared
1996-07-31
(83 days)
Product Code
Regulation Number
882.5900Type
TraditionalPanel
NEReference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
§ 882.5900 Preformed craniosynostosis strip.
(a)
Identification. A preformed craniosynostosis strip is a plastic strip used to cover bone edges of craniectomy sites (sites where the skull has been cut) to prevent the bone from regrowing in patients whose skull sutures are abnormally fused together.(b)
Classification. Class II (performance standards).