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K Number
K002619

Validate with FDA (Live)

Device Name
NEWGEN SYSTEM
Manufacturer
STRYKER INSTRUMENTS
Date Cleared
2000-11-16

(85 days)

Product Code
JEY
Regulation Number
872.4760
Type
Traditional
Panel
Dental
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K014263,K022185,K032520
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
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§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.