510(k) K231483

MySpine Unilateral Guides by Medacta International S.A. — Product Code PQC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 21, 2023
Date Received: May 23, 2023
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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Other clearances for product code PQC

K253472 — FIREFLY® Pedicle Screw Navigation Guide (February 25, 2026)
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K173472 — MySpine Pedicle Screw Placement Guides MC and Drill Pilot Instruments (April 19, 2018)
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