QSD · Class II · 21 CFR 888.3075

FDA Product Code QSD: Posterior Cervical Screw Placement Guide

A Posterior Cervical Screw Placement Guide Is Intended To Be Used As A Surgical Instrument To Assist In The Intra-operative Placement Of Posterior Cervical Screws That Are Used To Anchor Posterior Cervical Screw Systems On 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
239d
Avg days
2022
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

FDA 510(k) Cleared Posterior Cervical Screw Placement Guide Devices (Product Code QSD)

2 devices
1–2 of 2
Cleared Dec 07, 2023
MySpine Cervical Guides
K231515
Medacta International S.A.
Orthopedic · 196d

About Product Code QSD - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code QSD since 2022, with 2 receiving FDA clearance (average review time: 239 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.

QSD devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →