QVI · Class II · 21 CFR 888.3043

FDA Product Code QVI: Screw Sleeve Bone Fixation Device, Spine

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.

Leading manufacturers include Woven Orthopedic Technologies.

2
Total
2
Cleared
89d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Screw Sleeve Bone Fixation Device, Spine Devices (Product Code QVI)

2 devices
1–2 of 2
Cleared Oct 26, 2023
OGmend® Implant Enhancement System
K233223
Woven Orthopedic Technologies
Orthopedic · 28d
Cleared Feb 27, 2023
Ogmend® Implant Enhancement System
K223075
Woven Orthopedic Technologies
Orthopedic · 150d

About Product Code QVI - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code QVI since 2023, with 2 receiving FDA clearance (average review time: 89 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.

QVI devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →