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510(k) Data Aggregation
K Number
K093833Device Name
KAPSS SPINAL SYSTEM
Manufacturer
Date Cleared
2010-10-15
(305 days)
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
ROBERT REID INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The KAPSS® Spinal System is designed to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion.
The system is intended for posterior, pedicle fixation in skeletally mature patients for the treatment of the following acute and chronic instabilities or deformities: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.
The system is also intended for posterior, non-pedicle fixation for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD; defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture. dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.
Device Description
The KAPSS® Spinal System consists of longitudinal members (rods), anchors (screws and hooks), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety of sizes to accommodate differing anatomic requirements. The KAPSS® Spinal System is designed to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion.
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K Number
K093089Device Name
MAGNUM NAIL
Manufacturer
Date Cleared
2009-11-13
(43 days)
Product Code
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
ROBERT REID INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Magnum Nail is intended for use in fixation of stable and unstable fractures of the proximal femur. The types of proximal femoral fractures include pertrochanteric, intertrochanteric, basal neck fractures, high subtrochanteric fractures and combinations of these fractures. The Magnum Nail is also indicated for use in osteotomy, nonunions and malunions, bone reconstruction following tumor resection, grafting and pathological fractures and revision procedures.
Device Description
The Magnum Nail consists of nails, distal bone screws, cannulated lag screws, cannulated blades and set screws in a variety of sizes to accommodate differing anatomic requirements.
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