Mighty Oak Medical

FDA Device Registration & Listing · Englewood, CO, US · Registration 3011818499

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011818499
FEI Number
3011818499
Entity Name
Mighty Oak Medical
City/State/Country
Englewood, CO, US
Establishment Address
750 W Hampden Ave Ste 120, Englewood, CO 80110, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Mighty Oak Medical (Owner Number: 10050926)
Owner / Operator Contact Address
750 W. Hampden, Suite 120, Englewood, CO 80110, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K181883
PMA Number
N/A

All Registered Proprietary Names

FIREFLY Pedicle Screw Navigation Guide FIREFLY FIREFLY® Cervical Navigation Guide Midline Navigation Screw Guide

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PQC Pedicle Screw Placement Guide Orthopedic Class 2 888.3070 2016-11-03
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-01-18
QSD Posterior Cervical Screw Placement Guide Orthopedic Class 2 888.3075 2023-02-13
PQC Pedicle Screw Placement Guide Orthopedic Class 2 888.3070 2018-10-17

Official Correspondent

Mark Wylie

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Mighty Oak Medical
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K012175 Encore Orthopedics, Inc. PASS SPINAL SYSTEM 2001-07-31

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011818499. Last updated year: 2026. Please use registration number 3011818499 when referencing this establishment in official correspondence.
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