FIREFLY® Pedicle Screw Navigation Guide— 510(k) K253472

Name: FDA 510(k) clearance K253472
Creator: U.S. Food and Drug Administration
Published: 2026-02-25

Substantially Equivalent

Mighty Oak Medical

FDA 510(k) clearance K253472 for FIREFLY® Pedicle Screw Navigation Guide, Substantially Equivalent on 2026-02-25. Applicant: Mighty Oak Medical. Device class: 2.

Clearance details

Applicant: Mighty Oak Medical
Product code: Code PQC
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2025-10-10
Decision date: 2026-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PQC

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K231483 — MySpine Unilateral Guides2023-07-21
K203673 — MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)2021-04-06
K200792 — MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides2020-10-05
K181883 — FIREFLY® Midline Navigation Guide2018-10-03
K181399 — FIREFLY® Pedicle Screw Navigation Guide2018-07-24

More clearances from Mighty Oak Medical

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K260322 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)2026-06-11
K252103 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)2025-12-02
K251532 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)2025-11-03
K234009 — Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)2024-07-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.