MySpine Pedicle Screw Placement Guides – MC And Drill Pilot Instruments

Pedicle Screw Placement Guide

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Myspine Pedicle Screw Placement Guides – Mc And Drill Pilot Instruments.

Pre-market Notification Details

• Device ID: K173472
• 510k Number: K173472
• Device Name: MySpine Pedicle Screw Placement Guides – MC And Drill Pilot Instruments
• Classification: Pedicle Screw Placement Guide
• Applicant: Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874
• Contact: Stefano Baj
• Correspondent: Elizabeth Rose; Mapi USA, Inc 2343 Alexandria Drive, Suite 100 Lexington, KY 40504
• Product Code: PQC
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-11-09
• Decision Date: 2018-04-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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