MIGHTY OAK MEDICAL, INC.

MIGHTY OAK MEDICAL, INC.

Address:750 W Hampden Ave Ste 120,Englewood,CO,80110,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Orthosis, Spinal Pedicle Fixation (MNI) (10) Pedicle Screw Placement Guide (PQC) (10)

Premarket Exempt

No

Clear

FIREFLY® - 00851662007001 Catalog Number :

Device Description : Patient-Specific Pedicle Screw Guide

Device Class : 2

Duns Number: 024112263

Premarket Exempt : No

Product Code : MNI, PQC

Prescription Use : Yes

Device Count : 1

FIREFLY® - 00851662007018 Catalog Number :

Device Description : Patient-Specific Pedicle Screw Guide

Device Class : 2

Duns Number: 024112263

Premarket Exempt : No

Product Code : MNI, PQC

Prescription Use : Yes

Device Count : 1

FIREFLY® - 00851662007025 Catalog Number :

Device Description : Patient-Specific Bone Model

Device Class : 2

Duns Number: 024112263

Premarket Exempt : No

Product Code : MNI, PQC

Prescription Use : Yes

Device Count : 1

FIREFLY® - 00851662007032 Catalog Number :

Device Description : Instrument Sleeve

Device Class : 2

Duns Number: 024112263

Premarket Exempt : No

Product Code : MNI, PQC

Prescription Use : Yes

Device Count : 1

FIREFLY® - 00851662007049 Catalog Number :

Device Description : Fixation Screw

Device Class : 2

Duns Number: 024112263

Premarket Exempt : No

Product Code : MNI, PQC

Prescription Use : Yes

Device Count : 1

FIREFLY® - 00851662007056 Catalog Number :

Device Description : Fixation Screw

Device Class : 2

Duns Number: 024112263

Premarket Exempt : No

Product Code : MNI, PQC

Prescription Use : Yes

Device Count : 1

FIREFLY® - 00851662007063 Catalog Number :

Device Description : Screwdriver Bit

Device Class : 2

Duns Number: 024112263

Premarket Exempt : No

Product Code : MNI, PQC

Prescription Use : Yes

Device Count : 1

FIREFLY® - 00851662007070 Catalog Number :

Device Description : Screw Holding Sleeve

Device Class : 2

Duns Number: 024112263

Premarket Exempt : No

Product Code : MNI, PQC

Prescription Use : Yes

Device Count : 1

FIREFLY® - 00851662007087 Catalog Number :

Device Description : Drill Bit

Device Class : 2

Duns Number: 024112263

Premarket Exempt : No

Product Code : MNI, PQC

Prescription Use : Yes

Device Count : 1

FIREFLY® - 00851662007094 Catalog Number :

Device Description : Drill Bit

Device Class : 2

Duns Number: 024112263

Premarket Exempt : No

Product Code : MNI, PQC

Prescription Use : Yes

Device Count : 1

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