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510(k) K181399

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

K181399 is an FDA 510(k) premarket notification submitted by Mighty Oak Medical, Inc. for the device "FIREFLY® Pedicle Screw Navigation Guide". The FDA issued a decision of Substantially Equivalent on July 24, 2018. The device falls under product code PQC (Pedicle Screw Placement Guide), a Class II device regulated under 21 CFR 888.3070. Mighty Oak Medical, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2018
Date Received
May 29, 2018
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, Inc.

  • K260322 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) (June 11, 2026)
  • K253472 — FIREFLY® Pedicle Screw Navigation Guide (February 25, 2026)
  • 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)
  • K162419 — FIREFLY® Pedicle Screw Navigation Guide (October 28, 2016)
  • K143222 — FIREFLY Pedicle Screw Navigation Guide (December 11, 2015)

Other clearances for product code PQC

  • K253472 — FIREFLY® Pedicle Screw Navigation Guide (February 25, 2026)
  • 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)
  • K173472 — MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments (April 19, 2018)
  • K162419 — FIREFLY® Pedicle Screw Navigation Guide (October 28, 2016)

FDA data resources