Product code QVI

Device name
Screw Sleeve Bone Fixation Device, Spine
Medical specialty
Orthopedic
Device class
2
Regulation number
888.3043
Review panel
OR
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
A spinal screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone, and provides increased surface area to create an interference fit to restore stability of the implant construct.
Source
FDA openFDA device classification dataset