QLQ · Class II · 21 CFR 888.4515

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, Nuvasive, Inc. and Spinal Kinetics, LLC.

8
Total
8
Cleared
76d
Avg days
2021
Since
Stable submission activity - 3 submissions in the last 2 years
Review times increasing: avg 108d recently vs 57d historically

FDA 510(k) Cleared Manual Instruments Designed For Use With Total Disc Replacement Devices Devices (Product Code QLQ)

8 devices
1–8 of 8
Cleared Mar 27, 2026
Synergy Disc Instruments
K253392
Synergy Spine Solutions, Inc.
Orthopedic · 178d
Cleared Apr 25, 2025
prodisc® L Instruments
K250554
Centinel Spine, LLC
Orthopedic · 59d
Cleared Dec 17, 2024
prodisc® L Instruments
K242869
Centinel Spine, LLC
Orthopedic · 88d
Cleared Jun 21, 2024
M6-C™ Single Use, Disposable Instrumentation
K241117
Spinal Kinetics / Orthofix / Seaspine
Orthopedic · 59d
Cleared Jul 13, 2023
activL® Next Generation Instrumentation
K231769
Aesculap Implants Systems, LLC
Orthopedic · 27d
Cleared Aug 19, 2022
prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments
K221848
Centinel Spine, LLC
Orthopedic · 56d
Cleared Jun 02, 2022
M6-C Artificial Cervical Disc Instruments AS
K220861
Spinal Kinetics, LLC
Orthopedic · 70d
Cleared Aug 20, 2021
Simplify Disc
K211757
Nuvasive, Inc.
Orthopedic · 74d

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 remained relatively stable over the observed period, with 3 submissions in the last 24 months.

FDA 510(k) Review Time - QLQ Product Code

Recent submissions under QLQ have taken an average of 108 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 →