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K Number
K000594

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Device Name
LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE
Manufacturer
STRYKER LEIBINGER
Date Cleared
2000-12-08

(290 days)

Product Code
JEY
Regulation Number
872.4760
Type
Traditional
Panel
Dental
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K030448,K031701,K071612
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.