Screw Sleeve Bone Fixation Device, Spine
The Screw Sleeve Bone Fixation Device for Spine is an implantable device designed to be used in conjunction with a failed or loosened non-resorbable metallic bone screw in spinal fixation constructs, fitting between the screw threads and surrounding bone to increase surface area, create an interference fit, and restore construct stability. It addresses the clinical challenge of screw backout or loosening in spinal instrumentation. Classified as FDA Class 2 under regulation 888.3043, it requires 510(k) clearance in the Orthopedic specialty and is flagged as an implant. It is not life-sustaining.
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Basic Information
- Product Code
- QVI
- Device Class
- FDA class 2
- Regulation Number
- 888.3043
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.