Search Results
Found 1 results
510(k) Data Aggregation
K Number
K243281Device Name
LOCK-IN Spinal Fixation System
Manufacturer
Date Cleared
2024-12-13
(57 days)
Product Code
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
LOCK-IN USA CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The LOCK-IN Spinal Fixation System is intended for posterior, non-cervical fixation in skeletally 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; pseudarthrosis; and/or failed previous fusion.
The LOCK-IN Spinal Fixation System is intended to be used with autograft and/or allograft.
Device Description
The LOCK-IN Spinal Fixation System is a spinal pedicle fixation system consisting of polyaxial pedicle screws (expandable and non-expandable; cannulated and non-cannulated), rods (straight and curved), rod lockers, and crosslinks. All components are manufactured from Ti-6Al-4V ELI titanium alloy. All screws are available with either standard or spondylolisthesis head configurations. Fixation is provided via a posterior approach.
The LOCK-IN Spinal Fixation System expandable pedicle screws increase screw pullout strength when compared to similarly sized conventional screws. These screws are recommended for cases when increased fixation strength is desired.
The LOCK-IN Spinal Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion in the non-cervical spine, including the thoracic, lumbar and/or sacral spine (T1- S5). The LOCK-IN Spinal Fixation System consists of a variety of shapes and sizes of rods, screws, cross connectors that provide internal fixation and stabilization during bone graft healing and /or fusion mass development.
Ask a Question
Ask a specific question about this device
Page 1 of 1