PQC · Class II · 21 CFR 888.3070

FDA Product Code PQC: Pedicle Screw Placement Guide

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.

Leading manufacturers include Medacta International S.A..

2
Total
2
Cleared
85d
Avg days
2021
Since

List of Pedicle Screw Placement Guide devices cleared through 510(k)

2 devices
1–2 of 2
Cleared Jul 21, 2023
MySpine Unilateral Guides
K231483
Medacta International S.A.
Orthopedic · 59d
Cleared Apr 06, 2021
MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)
K203673
Medacta International S.A.
Orthopedic · 111d

How to use this database

This page lists all FDA 510(k) submissions for Pedicle Screw Placement Guide devices (product code PQC). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →