Cleared Special

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

Apr 2021

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K203673 is an FDA 510(k) clearance for the MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides), a Pedicle Screw Placement Guide (Class II — Special Controls, product code PQC), submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on April 6, 2021, 111 days after receiving the submission on December 16, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K203673 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 16, 2020
Decision Date	April 06, 2021
Days to Decision	111 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PQC — Pedicle Screw Placement Guide
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	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.