510(k) K253472

FIREFLY® Pedicle Screw Navigation Guide by Mighty Oak Medical — Product Code PQC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 25, 2026
Date Received: October 10, 2025
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.

Other clearances by Mighty Oak Medical

K252103 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (December 2, 2025)
K251532 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (November 3, 2025)
K234009 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (July 12, 2024)
K220132 — FIREFLY® Cervical Navigation Guide (October 26, 2022)
K181883 — FIREFLY® Midline Navigation Guide (October 3, 2018)
K181399 — FIREFLY® Pedicle Screw Navigation Guide (July 24, 2018)
K162419 — FIREFLY® Pedicle Screw Navigation Guide (October 28, 2016)
K143222 — FIREFLY Pedicle Screw Navigation Guide (December 11, 2015)

Other clearances for product code PQC

K231483 — MySpine Unilateral Guides (July 21, 2023)
K203673 — MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, My (April 6, 2021)
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)