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Sign in to claim this brandMighty Oak Medical
United States·US-MF-000039584
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 750, W Hampden Ave #120, Englewood, United States
- Website
- mightyoakmedical.com
- —
- —
- [email protected]
- Phone
- (720) 398-9703
- PRRC Contact
- Mark Wylie
- EUDAMED SRN
- US-MF-000039584
- FDA FEI Number
- 3011818499
- DUNS Number
- —
Catalogue (30)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Firefly® | FF-202-XX | FDA UDI | Class II | Active |
| Firefly® | FF-205-02 | FDA UDI | Class II | Active |
| Firefly® | FF-205-01 | FDA UDI | Class II | Active |
| Firefly® | FF-103-XX | FDA UDI | Class II | Active |
| Instrument Sleeve, Tap (FF-112-01) | FF-PSG-0007-00 | EUDAMEDFDA UDI | Class IIa | Active |
| Fixation Screw (FF-105-50) | FF-PSG-0007-00 | EUDAMEDFDA UDI | Class IIa | Active |
| FIREFLY® Pedicle Screw Navigation Guide | K253472 | FDA 510(k) | Class II | Active |
| FIREFLY Pedicle Screw Navigation Guide | K143222 | FDA 510(k) | Class II | Active |
| Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | K252103 | FDA 510(k) | Class II | Active |
| Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | K251532 | FDA 510(k) | Class II | Active |
| FIREFLY® Midline Navigation Guide | K181883 | FDA 510(k) | Class II | Active |
| FIREFLY® Pedicle Screw Navigation Guide | K162419 | FDA 510(k) | Class II | Active |
| FIREFLY® Pedicle Screw Navigation Guide | K181399 | FDA 510(k) | Class II | Active |
| Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX) | K234009 | FDA 510(k) | Class II | Active |
| FIREFLY® Cervical Navigation Guide | K220132 | FDA 510(k) | Class II | Active |
| Patient-Specific Pedicle Screw Guide (FF-101-XX) | FF-PSG-0007-00 | EUDAMEDFDA UDI | Class IIa | Active |
| Instrument Sleeve (FF-104-32) | FF-PSG-0007-00 | EUDAMEDFDA UDI | Class IIa | Active |
| Instrument Sleeve, Ø2.0 Drill (FF-104-20 ) | FF-PSG-0007-00 | EUDAMEDFDA UDI | Class IIa | Active |
| Reamer (FF-114-01) | FF-PSG-0007-00 | EUDAMEDFDA UDI | Class IIa | Active |
| Drill Bit, Ø3.2 AO (FF-110-01) | FF-PSG-0007-00 | EUDAMEDFDA UDI | Class IIa | Active |
| Handle (FF-111-01) | FF-PSG-0007-00 | EUDAMEDFDA UDI | Class IIa | Active |
| Pedicle Marker (FF-113-02) | FF-PSG-0007-00 | EUDAMEDFDA UDI | Class IIa | Active |
| Screw Holding Sleeve (FF-107-01) | FF-PSG-0007-00 | EUDAMEDFDA UDI | Class IIa | Active |
| Screwdriver Bit (FF-106-100) | FF-PSG-0007-00 | EUDAMEDFDA UDI | Class IIa | Active |
| Pedicle Marker (FF-113-01) | FF-PSG-0007-00 | EUDAMEDFDA UDI | Class IIa | Active |
| Drill Bit, Ø2.0 AO (FF-110-03) | FF-PSG-0007-00 | EUDAMEDFDA UDI | Class IIa | Active |
| Fixation Screw (FF-105-24) | FF-PSG-0007-00 | EUDAMEDFDA UDI | Class IIa | Active |
| Drill Bit, Ø3.2 Jacobs (FF-110-02) | FF-PSG-0007-00 | EUDAMEDFDA UDI | Class IIa | Active |
| Drill Bit, Ø2.0 Jacobs (FF-110-04) | FF-PSG-0007-00 | EUDAMEDFDA UDI | Class IIa | Active |
| Patient-Specific Pedicle Screw Guide (FF-102-XX) | FF-PSG-0007-00 | EUDAMEDFDA UDI | Class IIa | Active |
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