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Company · US

Mighty Oak Medical, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2026. Name variants (Inc, Corp, punctuation) are merged.

10510(k) clearances (3 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
PQC	Pedicle Screw Placement Guide	4
QIH	Automated Radiological Image Processing Software	3
LLZ	System, Image Processing, Radiological	1
MNI	Orthosis, Spinal Pedicle Fixation	1
QSD	Posterior Cervical Screw Placement Guide	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Jun 11, 2026	K260322	Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) Mighty Oak Medical	QIH
Feb 25, 2026	K253472	FIREFLY® Pedicle Screw Navigation Guide Mighty Oak Medical	PQC
Dec 2, 2025	K252103	Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) Mighty Oak Medical	QIH
Nov 3, 2025	K251532	Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) Mighty Oak Medical	LLZ
Jul 12, 2024	K234009	Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) Mighty Oak Medical	QIH
Oct 26, 2022	K220132	FIREFLY® Cervical Navigation Guide Mighty Oak Medical, Inc.	QSD
Oct 3, 2018	K181883	FIREFLY® Midline Navigation Guide Mighty Oak Medical, Inc.	PQC
Jul 24, 2018	K181399	FIREFLY® Pedicle Screw Navigation Guide Mighty Oak Medical, Inc.	PQC
Oct 28, 2016	K162419	FIREFLY® Pedicle Screw Navigation Guide Mighty Oak Medical, Inc.	PQC
Dec 11, 2015	K143222	FIREFLY Pedicle Screw Navigation Guide Mighty Oak Medical, Inc.	MNI

Latest recalls

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.

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