Data / Medical devices / United States / Mighty Oak Medical
Mighty Oak Medical: FDA-registered device maker in Englewood, CO, United States, 5 510(k) clearances
Mighty Oak Medical is registered with the FDA (registration 3011818499) in Englewood, CO, United States. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 26, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011818499
- Address
- 750 W Hampden Ave Ste 120, Englewood, CO, United States, 80110
- Owner or operator
- Mighty Oak Medical (10050926)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 18, 2016
- Registered through
- 2026
- Brand names listed
- FIREFLY, FIREFLY Pedicle Screw Navigation Guide, FIREFLY® Cervical Navigation Guide, Midline Navigation Screw Guide, Pedicle screw placement guide
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Pedicle Screw Placement Guide | PQC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Posterior Cervical Screw Placement Guide | QSD | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 26, 2022 | K220132 | FIREFLY® Cervical Navigation Guide | QSD | Substantially Equivalent | Mighty Oak Medical, Inc. | accessdata.fda.gov |
| October 3, 2018 | K181883 | FIREFLY® Midline Navigation Guide | PQC | Substantially Equivalent | Mighty Oak Medical, Inc. | accessdata.fda.gov |
| July 24, 2018 | K181399 | FIREFLY® Pedicle Screw Navigation Guide | PQC | Substantially Equivalent | Mighty Oak Medical, Inc. | accessdata.fda.gov |
| October 28, 2016 | K162419 | FIREFLY® Pedicle Screw Navigation Guide | PQC | Substantially Equivalent | Mighty Oak Medical, Inc. | accessdata.fda.gov |
| December 11, 2015 | K143222 | FIREFLY Pedicle Screw Navigation Guide | MNI | Substantially Equivalent | Mighty Oak Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthosis, Spinal Pedicle Fixation
- All makers of Pedicle Screw Placement Guide
- All makers of Posterior Cervical Screw Placement Guide
Updated October 26, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.