QLQClass II

Manual Instruments Designed For Use With Total Disc Replacement Devices

21 CFR 888.4515 / Orthopedic

QLQ is the FDA product code for Manual Instruments Designed For Use With Total Disc Replacement Devices, a class II device type, regulated under 21 CFR 888.4515. FDA's definition for this code reads: "The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices". As of 2026-09-10, FDA records hold 9 510(k) clearances under this code, the most recent dated 2026-08-14, and no recalls.

Classification record

Product code: QLQ
Device name: Manual Instruments Designed For Use With Total Disc Replacement Devices
FDA definition: The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices.
Regulation: 21 CFR 888.4515
Device class: Class II
Review panel: Orthopedic
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 9
Ingested recalls: 0

Clearances, product code QLQ

By decision year

9 clearances under product code QLQ with a decision year between 2021 and 2026, 2022 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code QLQ by decision year
Year	Clearances
2021	1
2022	2
2023	1
2024	2
2025	1
2026	2

Applicants with the most clearances

Product code QLQ

Applicants holding the most 510(k) clearances under product code QLQ
Applicant	Clearances
Centinel Spine, LLC	3
Aesculap Implants Systems, LLC	1
NuVasive Inc	1
Spinal Kinetics / Orthofix / Seaspine	1
Spinal Kinetics, LLC	1
Spineart SA	1
Synergy Spine Solutions Inc	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order