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K Number
K083089

Validate with FDA (Live)

Device Name
NEWPORT SPINAL SYSTEM
Manufacturer
SEASPINE, INC.
Date Cleared
2009-01-13

(89 days)

Product Code
NKB,MNH,MNI
Regulation Number
888.3070
Type
Traditional
Panel
Orthopedic
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K160902,K161535,K180176
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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N/A