DeviceClearance

Product code QLR— Orthopedic

Companion Spine DIAM Instrumentation

Classification name
Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices
Device class
Class 2
Regulation
21 CFR 888.4520
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QLR under 21 CFR 888.4520, via openFDA

Market context for product code QLR

FDA has cleared 1 device under product code QLR, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QLR

Recent clearances under product code QLR

Data sourced from openFDA. This site is unofficial and independent of the FDA.