DeviceClearance

Product code PQC— Orthopedic

FIREFLY® Pedicle Screw Navigation Guide

Classification name
Pedicle Screw Placement Guide
Device class
Class 2
Regulation
21 CFR 888.3070
Advisory panel
Orthopedic
Total cleared
8
First cleared
Most recent

FDA classification definition

“A pedicle screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of pedicle screws that are used to anchor pedicle screw spinal systems onto 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 PQC under 21 CFR 888.3070, via openFDA

Market context for product code PQC

FDA has cleared 8 devices under product code PQC between 2016 and 2026, filed by 4 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 PQC

Recent clearances under product code PQC

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