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K Number
K000580
Device Name
ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15
Manufacturer
KLS-MARTIN L.P.
Date Cleared
2000-07-24

(153 days)

Product Code
MQN
Regulation Number
872.4760
Type
Traditional
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
K161470
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis 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.