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K Number
K002423

Validate with FDA (Live)

Device Name
LACTOSORB PUSH SCREW
Manufacturer
BIOMET, INC.
Date Cleared
2000-10-20

(73 days)

Product Code
DZL
Regulation Number
872.4880
Type
Traditional
Panel
Dental
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K021522
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.