QLR

Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices

Product code
QLR
Device name
Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices
Device class
Class 2
21 CFR
21 CFR 888.4520
Medical specialty
Orthopedic
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1

FDA classification definition

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.

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

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-12-16.

NumberDecision dateApplicantDevice nameSummary
K2531182025-12-16Companion Spine FranceCompanion Spine DIAM™ InstrumentationPDF

1 summaries are archived here for direct download.

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