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510(k) K220132

FIREFLY® Cervical Navigation Guide by Mighty Oak Medical, Inc. — Product Code QSD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2022
Date Received
January 18, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Posterior Cervical Screw Placement Guide
Device Class
Class II
Regulation Number
888.3075
Review Panel
OR
Submission Type

A posterior cervical screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of posterior cervical screws that are used to anchor posterior cervical screw systems on 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.

  • 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)
  • 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 QSD

  • K231515 — MySpine Cervical Guides (December 7, 2023)