FIREFLY Pedicle Screw Navigation Guide— 510(k) K143222

Name: FDA 510(k) clearance K143222
Creator: U.S. Food and Drug Administration
Published: 2015-12-11

Substantially Equivalent

Mighty Oak Medical, Inc.

FDA 510(k) clearance K143222 for FIREFLY Pedicle Screw Navigation Guide, Substantially Equivalent on 2015-12-11. Applicant: Mighty Oak Medical, Inc.. Device class: 2.

Clearance details

Applicant: Mighty Oak Medical, Inc.
Product code: Code MNI
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2014-11-10
Decision date: 2015-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

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K151458 — Double Medical Universal Spine System2016-08-22
K153273 — MySpine Pedicle Screw Placement Guides - LP2016-06-29
K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System2016-04-04

More clearances from Mighty Oak Medical, Inc.

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K220132 — FIREFLY® Cervical Navigation Guide2022-10-26
K181883 — FIREFLY® Midline Navigation Guide2018-10-03
K181399 — FIREFLY® Pedicle Screw Navigation Guide2018-07-24
K162419 — FIREFLY® Pedicle Screw Navigation Guide2016-10-28

Adverse events under product code MNI

product code MNI

Injury: 641
Total: 641

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.