QVI — Screw Sleeve Bone Fixation Device, Spine Class II
FDA product code QVI covers "Screw Sleeve Bone Fixation Device, Spine", a Class II medical device regulated under 21 CFR 888.3043. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QVI
- Device Class
- Class II
- Regulation Number
- 888.3043
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
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.