Product code QVI— Orthopedic
OGmend® Implant Enhancement System
- Classification name
- Screw Sleeve Bone Fixation Device, Spine
- Device class
- Class 2
- Regulation
- 21 CFR 888.3043
- Advisory panel
- Orthopedic
- Total cleared
- 2
- First cleared
- Most recent
FDA classification 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.”
Market context for product code QVI
FDA has cleared devices under product code QVI, all in 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code QVI
Recent clearances under product code QVI
Data sourced from openFDA. This site is unofficial and independent of the FDA.