FIREFLY® Pedicle Screw Navigation Guide— 510(k) K253472
Substantially EquivalentMighty 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.
Summary
Mighty Oak Medical's FIREFLY® Pedicle Screw Navigation Guide is filed under product code PQC, pedicle screw placement guide. The record doesn't describe the guide beyond its name and that code name.
Class II, 21 CFR 888.3070. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Mighty Oak Medical filed from Englewood, Colorado. The decision came 138 calendar days after FDA received it (October 10, 2025 to February 25, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Mighty Oak Medical
- Product code
- Product code PQC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Englewood, CO, US
Recent devices under product code PQC
view all- K231483 — MySpine Unilateral Guides
- K203673 — MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)
- K200792 — MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides
- K181883 — FIREFLY® Midline Navigation Guide
- K181399 — FIREFLY® Pedicle Screw Navigation Guide
More clearances from Mighty Oak Medical
view allData sourced from openFDA. This site is unofficial and independent of the FDA.