FDA.reportPublic FDA data

Mighty Oak Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30118184993011818499Mighty Oak Medical1N2026-01-01750 W Hampden Ave Ste 120 Englewood CO US 80110

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1904201193452863K220132FIREFLY® Cervical Navigation GuideQSD2022-10-26
1904201191413471K181883FIREFLY® Midline Navigation GuidePQC2018-10-03
1904201619730842K181399FIREFLY® Pedicle Screw Navigation GuidePQC2018-07-24
1904201809542516K162419FIREFLY® Pedicle Screw Navigation GuidePQC2016-10-28
1904201941014137K143222FIREFLY Pedicle Screw Navigation GuideMNI2015-12-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PQC32018-10-03
QSD12022-10-26
MNI12015-12-11

PMN#