Cleared Traditional

K200792 - MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides
(FDA 510(k) Clearance)

K200792 · Medacta Inernational SA · Orthopedic

Oct 2020

Decision

193d

Days

Class 2

Risk

K200792 is an FDA 510(k) clearance for the MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides, a Pedicle Screw Placement Guide (Class II — Special Controls, product code PQC), submitted by Medacta Inernational SA (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on October 5, 2020, 193 days after receiving the submission on March 26, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K200792 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 26, 2020
Decision Date	October 05, 2020
Days to Decision	193 days
Submission Type	Traditional
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.