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510(k) Data Aggregation
K Number
K151770Device Name
Libra Pedicle Screw System
Manufacturer
Date Cleared
2015-11-20
(143 days)
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Spinal Balance Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Libra Pedicle Screw System is intended for immobilization of the posterior thoracic, lumbar and sacral/iliac spine (TI-S1/Ilium) in skeletally mature patients as an adjunct to the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Device Description
The Libra Pedicle Screw System consists of longitudinal members (rods), anchors (screws) and fasteners in a variety of sizes to accommodate differing anatomic requirements.
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