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510(k) Data Aggregation
K Number
K201457Device Name
Auxein Brand Vertaux 5.5 mm Pedicle Screw System
Manufacturer
Auxein Medical Private Limited/71164
Date Cleared
2021-04-06
(309 days)
Product Code
NKB
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Auxein Medical Private Limited/71164
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Auxein Brand Vertaux 5.5 mm Pedicle Screw System is intended for posterical fixation in sketally mature patients as an adjunct to fusion for 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 and/or lordosis);
·Tumor and pseudarthrosis
Device Description
Auxein Brand Vertaux 5.5 mm Pedicle Screw System consists of rods, connectors and screws for implantation in the spine. The system is available in multiple rod diameters and screw sizes.
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