FDA Product Code QLR: Manual Instruments Designed For Use With Non-fusion Spinous Process Spacer Devices
The Devices Are Intended To Manipulate Tissue Or Implant Materials For The Positioning, Alignment, Placement, Or Removal Of Spinous Process Spacer Devices For Non-fusion Use.
Leading manufacturers include Companion Spine France.
FDA 510(k) Cleared Manual Instruments Designed For Use With Non-fusion Spinous Process Spacer Devices Devices (Product Code QLR)
About Product Code QLR - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QLR since 2025, with 1 receiving FDA clearance (average review time: 83 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
QLR devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →