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510(k) Data Aggregation
K Number
K182352Device Name
SP-LINK System
Manufacturer
Date Cleared
2018-11-21
(84 days)
Product Code
Regulation Number
888.3050Why did this record match?
Applicant Name (Manufacturer) :
Medical Designs LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SP-LINK™ System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for single level plate attachment to the spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The SP-LINK™ System is intended for use with bone graft material, and not for stand-alone use.
Device Description
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