510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220132Substantially Equivalent

FIREFLY® Cervical Navigation Guide

Mighty Oak Medical, Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220132 is the FDA 510(k) clearance record for FIREFLY® Cervical Navigation Guide, a class II device, cleared for Mighty Oak Medical, Inc. on under FDA product code QSD (Posterior Cervical Screw Placement Guide). FDA's definition for product code QSD reads: "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...". FDA records list 10 510(k) clearances for Mighty Oak Medical, Inc., from to . As of , FDA records show no recalls naming K220132.

Clearance record

Decision date
Received
(281 days to decision)
Product code
QSD Posterior Cervical Screw Placement Guide
Regulation
21 CFR 888.3075
Device class
Class II
Review panel
Orthopedic
Applicant
Mighty Oak Medical, Inc. 750 W. Hampden Ave., Englewood CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QSD

Trailing 12 months

FDA records hold no clearances under product code QSD in the trailing twelve months.

FDA records show no clearances under product code QSD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QSD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260