Mighty Oak Medical
Englewood, CO, US
Mighty Oak Medical appears in FDA device records in Englewood, CO. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Mighty Oak Medical between 2015 and 2026. The busiest year on record is 2018, with 2. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 2 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 2 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260322 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | QIH | Substantially Equivalent | |
| K253472 | FIREFLY® Pedicle Screw Navigation Guide | PQC | Substantially Equivalent | |
| K252103 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | QIH | Substantially Equivalent | |
| K251532 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | LLZ | Substantially Equivalent | |
| K234009 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | QIH | Substantially Equivalent | |
| K220132 | FIREFLY® Cervical Navigation Guide | QSD | Substantially Equivalent | |
| K181883 | FIREFLY® Midline Navigation Guide | PQC | Substantially Equivalent | |
| K181399 | FIREFLY® Pedicle Screw Navigation Guide | PQC | Substantially Equivalent | |
| K162419 | FIREFLY® Pedicle Screw Navigation Guide | PQC | Substantially Equivalent | |
| K143222 | FIREFLY Pedicle Screw Navigation Guide | MNI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011818499 | 3011818499 | Mighty Oak Medical | 750 W Hampden Ave Ste 120, Englewood, CO 80110 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain