510(k) K241895

Cannulated PsiFGuard by Spineguard — Product Code SCY

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 26, 2024
Date Received: June 28, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Sacroiliac Joint Guidewire Placement Device
Device Class: Class II
Regulation Number: 888.3040
Review Panel: OR
Submission Type

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.

Other clearances by Spineguard

K220160 — PediGuard Threaded (March 31, 2022)
K201454 — DSG Connect Technology (February 10, 2021)
K162884 — SpineGuard DSG Zavation Screw System (January 12, 2017)
K152747 — DSG Threaded Drill System (June 10, 2016)
K143159 — Cannulated PediGuard Needle#1, Cannulated PediGuard Needle#2, Cannulated PediGua (January 23, 2015)
K123390 — PEDIGUARD NERVE DETECTOR SYSTEM (August 8, 2013)