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510(k) Data Aggregation
K Number
K130731Device Name
STABILIZ FIXATION SYSTEM - SPL LOCKING SCREW
Manufacturer
Date Cleared
2013-07-19
(123 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
STABILIZ ORTHOPAEDICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Stabiliz Fixation System with SPL Locking Screw is intended for fixation of fractures, osteotomies and nonunions of the humerus, radius, ulna, distal tibia, and fibula.
Device Description
The Stabiliz Fixation System includes standard straight LCP plates, metal locking screws, cortical screws, fully-threaded cancellous screws, and partially-threaded cancellous screws in various sizes and geometries. The SPL Locking Screw is a metal locking screw with a resorbable threaded polymer collar.
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K Number
K120651Device Name
STABILIZ FIXATION SYSTEM
Manufacturer
Date Cleared
2012-11-27
(270 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
STABILIZ ORTHOPAEDICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Stabiliz Fixation System is intended for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.
Device Description
The Stabiliz Fixation System includes standard straight LCP plates, metal locking screws, cortical screws, and fully-threaded and partially-threaded cancellous screws in various sizes and geometries.
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Ask a specific question about this device
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