510(k) K173472

MySpine Pedicle Screw Placement Guides MC and Drill Pilot Instruments by Medacta International S.A. — Product Code PQC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 19, 2018
Date Received: November 9, 2017
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Pedicle Screw Placement Guide
Device Class: Class II
Regulation Number: 888.3070
Review Panel: OR
Submission Type

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.

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