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K Number
K010527
Device Name
SYNTHES (USA) IMF SCREWS
Manufacturer
SYNTHES (USA)
Date Cleared
2001-04-25

(62 days)

Product Code
DZL
Regulation Number
872.4880
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 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.