Cleared Traditional

MySpine Cervical Guides

K231515 · Medacta International S.A. · Orthopedic
Dec 2023
Decision
196d
Days
Class 2
Risk

About This 510(k) Submission

K231515 is an FDA 510(k) clearance for the MySpine Cervical Guides, a Posterior Cervical Screw Placement Guide (Class II — Special Controls, product code QSD), submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on December 7, 2023, 196 days after receiving the submission on May 25, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3075.

Submission Details

510(k) Number K231515 FDA.gov
FDA Decision Cleared SESE
Date Received May 25, 2023
Decision Date December 07, 2023
Days to Decision 196 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code QSD — Posterior Cervical Screw Placement Guide
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3075
Definition 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.