FIREFLY® Cervical Navigation Guide— 510(k) K220132

Name: FDA 510(k) clearance K220132
Creator: U.S. Food and Drug Administration
Published: 2022-10-26

Substantially Equivalent

Mighty Oak Medical, Inc.

FDA 510(k) clearance K220132 for FIREFLY® Cervical Navigation Guide, Substantially Equivalent on 2022-10-26. Applicant: Mighty Oak Medical, Inc.. Device class: 2.

Clearance details

Applicant: Mighty Oak Medical, Inc.
Product code: Code QSD
Device class: Class 2
Regulation: 21 CFR 888.3075
Advisory panel: Orthopedic
Date received: 2022-01-18
Decision date: 2022-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

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K231515 — MySpine Cervical Guides2023-12-07

More clearances from Mighty Oak Medical, Inc.

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K181883 — FIREFLY® Midline Navigation Guide2018-10-03
K181399 — FIREFLY® Pedicle Screw Navigation Guide2018-07-24
K162419 — FIREFLY® Pedicle Screw Navigation Guide2016-10-28
K143222 — FIREFLY Pedicle Screw Navigation Guide2015-12-11

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