DeviceClearance

Product code SCY— Orthopedic

Cannulated PsiFGuard

Classification name
Sacroiliac Joint Guidewire Placement Device
Device class
Class 2
Regulation
21 CFR 888.3040
Advisory panel
Orthopedic
Total cleared
1
First cleared
Most recent

FDA classification definition

“A sacroiliac joint guidewire placement device is intended to be used to assist in locating the sacroiliac joint and placing a guidewire in the joint as part of sacroiliac joint fusion surgeries to place implants into the sacroiliac joint.”

— U.S. Food and Drug Administration, device classification record for product code SCY under 21 CFR 888.3040, via openFDA

Market context for product code SCY

FDA has cleared 1 device under product code SCY, all in 2024, 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 SCY

Recent clearances under product code SCY

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