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510(k) Data Aggregation
K Number
K213266Device Name
Inspan ScrewLES Fusion System
Manufacturer
LESpine Innovations, LLC
Date Cleared
2021-12-03
(64 days)
Product Code
PEK
Regulation Number
888.3050Why did this record match?
Applicant Name (Manufacturer) :
LESpine Innovations, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Inspan ScrewLES Fusion System is a posterior non-pedicle supplemental fixation system intended for use in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion for the following indications: spondylolisthesis, trauma (fracture or dislocation), tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radios), or lumbar spinal stenosis. The device is intended for use with bone graft material and is not intended for stand-alone use.
Device Description
The Inspan ScrewLES Fusion System, previously cleared (under K102020) and marketed as, "Vega™ SPANTM Spinous Process Plate System", consists of varying length and hub diameters, set screws, and instruments required for implantation. Spikes are present on the sides of the plate that interface with the spinous process to restrain the plate from rotating postoperatively. The device is offered with varying lengths and hub diameters to accommodate anatomical needs. Set screws are used to secure the two sides of the device into the final compressed and implanted construct.
System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.
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