DeviceClearance

Product code QSD— Orthopedic

FIREFLY® Cervical Navigation Guide

Classification name
Posterior Cervical Screw Placement Guide
Device class
Class 2
Regulation
21 CFR 888.3075
Advisory panel
Orthopedic
Total cleared
2
First cleared
Most recent

FDA classification definition

“A posterior cervical screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of posterior cervical screws that are used to anchor posterior cervical screw systems on the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on pre-operative imaging scans.”

— U.S. Food and Drug Administration, device classification record for product code QSD under 21 CFR 888.3075, via openFDA

Market context for product code QSD

FDA has cleared 2 devices under product code QSD between 2022 and 2023, filed by 2 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 QSD

Recent clearances under product code QSD

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