FDA Product Code QLQ: Manual Instruments Designed For Use With Total Disc Replacement Devices
The Devices Are Intended To Manipulate Tissue Or Implant Materials For The Positioning, Alignment, Defect Creation, Placement, Or Removal Of Total Disc Replacement Devices.
Leading manufacturers include Centinel Spine, LLC, Synergy Spine Solutions, Inc. and Nuvasive, Inc..
FDA 510(k) Cleared Manual Instruments Designed For Use With Total Disc Replacement Devices Devices (Product Code QLQ)
About Product Code QLQ - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code QLQ since 2021, with 8 receiving FDA clearance (average review time: 76 days).
Submission volume has increased in recent years - 4 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QLQ have taken an average of 96 days to reach a decision - up from 57 days historically. Manufacturers should account for longer review timelines in current project planning.
QLQ devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →