DeviceClearance

Product code QLQ— Orthopedic

prodisc® L Instruments

Classification name
Manual Instruments Designed For Use With Total Disc Replacement Devices
Device class
Class 2
Regulation
21 CFR 888.4515
Advisory panel
Orthopedic
Total cleared
9
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QLQ under 21 CFR 888.4515, via openFDA

Market context for product code QLQ

FDA has cleared 9 devices under product code QLQ between 2021 and 2026, filed by 7 applicant companies. 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.

Clearances per year

Top applicants under product code QLQ

Recent clearances under product code QLQ

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