FDA.reportPublic FDA data

510(k) K220132

Device
FIREFLY® Cervical Navigation Guide
Applicant
Mighty Oak Medical Inc.
510(k) number
K220132
Product code
QSD  
Decision
Substantially Equivalent (SESE)
Decision date
2022-10-26
Date received
2022-01-18
Regulation
888.3075
Classification name
Posterior Cervical Screw Placement Guide
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Mark A. Wylie
Address
750 W. Hampden Ave. Suite 120 Englewood CO US 80110 80110

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QSD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231515MySpine Cervical GuidesMedacta International S.A.2023-12-07

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases