SCY — Sacroiliac Joint Guidewire Placement Device Class II

FDA Device Classification

Classification Details

Product Code
SCY
Device Class
Class II
Regulation Number
888.3040
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241895spineguardCannulated PsiFGuardSeptember 26, 2024