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510(k) Data Aggregation
K Number
K090063Device Name
MERETE LOCKING BONE PLATE SYSTEM
Manufacturer
MERETE MEDICAL, INC.
Date Cleared
2009-04-22
(103 days)
Product Code
KTT
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
MERETE MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Merete Locking Bone Plate System can be used for adult and pediatric patients. Indications for use include fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers, and toes.
Device Description
The Merete Locking Bone Plate System consists of contoured, anatomically shaped locking bone plates in various sizes and different curvatures, Merete 3.0mm and 3.5mm locking screws and cannulated 3.0mm compression screws. The system is made of titanium alloy Ti-6Al-4V.
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