510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181399Substantially Equivalent

FIREFLY® Pedicle Screw Navigation Guide

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

K181399 is the FDA 510(k) clearance record for FIREFLY® Pedicle Screw Navigation Guide, a class II device, cleared for Mighty Oak Medical, Inc. on under FDA product code PQC (Pedicle Screw Placement Guide). FDA's definition for product code PQC reads: "A pedicle screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of pedicle screws that are used to anchor pedicle screw spinal systems onto the posterior elements of the spine. The...". FDA records list 10 510(k) clearances for Mighty Oak Medical, Inc., from to . As of , FDA records show no recalls naming K181399.

Clearance record

Decision date
Received
(56 days to decision)
Product code
PQC Pedicle Screw Placement Guide
Regulation
21 CFR 888.3070
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 PQC

Trailing 12 months
1 clearance under product code PQC in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PQC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260