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K Number
K963740

Validate with FDA (Live)

Device Name
LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS
Manufacturer
HOWMEDICA LEIBINGER, INC.
Date Cleared
1996-10-28

(41 days)

Product Code
JEY
Regulation Number
872.4760
Type
Traditional
Panel
Dental
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K963030,K970912
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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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.