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Mighty Oak Medical

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253472FIREFLY® Pedicle Screw Navigation GuideFebruary 25, 2026
K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)December 2, 2025
K251532Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)November 3, 2025
K234009Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)July 12, 2024
K220132FIREFLY® Cervical Navigation GuideOctober 26, 2022
K181883FIREFLY® Midline Navigation GuideOctober 3, 2018
K181399FIREFLY® Pedicle Screw Navigation GuideJuly 24, 2018
K162419FIREFLY® Pedicle Screw Navigation GuideOctober 28, 2016
K143222FIREFLY Pedicle Screw Navigation GuideDecember 11, 2015