QLQ

Manual Instruments Designed For Use With Total Disc Replacement Devices

Product code
QLQ
Device name
Manual Instruments Designed For Use With Total Disc Replacement Devices
Device class
Class 2
21 CFR
21 CFR 888.4515
Medical specialty
Orthopedic
Marketing pathway
510(K)
510(k) clearances (last 3 years)
9

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2026-08-14.

NumberDecision dateApplicantDevice nameSummary
K2626392026-08-14Spineart SABAGUERA® C Cervical Disc Surgical InstrumentsPDF
K2533922026-03-27Synergy Spine Solutions, Inc.Synergy Disc InstrumentsPDF
K2505542025-04-25Centinel Spine, LLCprodisc® L InstrumentsPDF
K2428692024-12-17Centinel Spine, LLCprodisc® L InstrumentsPDF
K2411172024-06-21Spinal Kinetics / Orthofix / SeaspineM6-C™ Single Use, Disposable InstrumentationPDF

5 summaries are archived here for direct download.

Official FDA classification page: QLQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).