SCY

Sacroiliac Joint Guidewire Placement Device

Product code: SCY
Device name: Sacroiliac Joint Guidewire Placement Device
Device class: Class 2
21 CFR: 21 CFR 888.3040
Medical specialty: Orthopedic
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 1

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-09-26.

Number	Decision date	Applicant	Device name	Summary
K241895	2024-09-26	Spineguard	Cannulated PsiFGuard	PDF

1 summaries are archived here for direct download.

Official FDA classification page: SCY

Classification and pathway per current FDA publications. Data from openFDA (CC0).