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510(k) K143222

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2015
Date Received
November 10, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Spinal Pedicle Fixation
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Other clearances by Mighty Oak Medical, Inc.

  • 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)
  • K181399 — FIREFLY® Pedicle Screw Navigation Guide (July 24, 2018)
  • K162419 — FIREFLY® Pedicle Screw Navigation Guide (October 28, 2016)

Other clearances for product code MNI

  • K171497 — Mikron Spinal Fixation System (October 12, 2017)
  • K160731 — LumFix Spinal Fixation Sytem (October 4, 2016)
  • K151458 — Double Medical Universal Spine System (August 22, 2016)
  • K153273 — MySpine Pedicle Screw Placement Guides - LP (June 29, 2016)
  • K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation (April 4, 2016)
  • K160320 — Premier (April 1, 2016)
  • K160003 — Sniper (R) Spine System (February 26, 2016)
  • K152324 — YAHUA Spinal System (February 1, 2016)
  • K150684 — WASTON General Spinal System (November 18, 2015)
  • K152132 — X-spine Pedicle Screw System (September 25, 2015)