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510(k) Data Aggregation
K Number
K242350Device Name
Spinal Alignment Solutions Pelvic Incidence (PI) Rod System
Manufacturer
Spinal Alignment Solutions, Inc.
Date Cleared
2024-10-28
(81 days)
Product Code
NKB
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Spinal Alignment Solutions, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spinal Alignment Solutions Pelvic Incidence (PI) Rod System is indicated for the use with Medtronic CD Horizon™ SOLERA™ Spinal System which is intended for posterior, lumbar and sacral fixation in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (DDD - 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, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Device Description
The Spinal Alignment Solutions Pelvic Incidence (PI) Rod System consists of pre-bent spinal rods compatible for use with the Medtronic CD Horizon™ SOLERA™ Spinal System. The SAS PI Rod System is manufactured from either titanium alloy or cobalt chrome.
The CD Horizon™ Spinal System consists of a variety of shapes and size of rods, screws, CROSSLINK® Plates, and connecting components which can be rigidly locked into avariety of configurations, with each construct being tailor-made for the individual case.
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