Home / 510(k) Clearances / K203673

510(k) K203673

MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides) by Medacta International S.A. — Product Code PQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2021
Date Received
December 16, 2020
Clearance Type
Special
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)
  • K231483 — MySpine Unilateral Guides (July 21, 2023)
  • K200792 — MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides (October 5, 2020)
  • K181883 — FIREFLY® Midline Navigation Guide (October 3, 2018)
  • K181399 — FIREFLY® Pedicle Screw Navigation Guide (July 24, 2018)
  • K173472 — MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments (April 19, 2018)
  • K162419 — FIREFLY® Pedicle Screw Navigation Guide (October 28, 2016)