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K Number
K113512
Device Name
BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM
Manufacturer
BIOMET MICROFIXATION
Date Cleared
2012-06-29

(214 days)

Product Code
JEY
Regulation Number
872.4760
Type
Special
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
K131674
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 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.