The following data is part of a premarket notification filed by Mighty Oak Medical Inc with the FDA for Firefly Pedicle Screw Navigation Guide.
| Device ID | K143222 |
| 510k Number | K143222 |
| Device Name: | FIREFLY Pedicle Screw Navigation Guide |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | Mighty Oak Medical Inc 777 E Girard Ave. STE 150 Englewood, CO 80113 |
| Contact | Heidi Frey |
| Correspondent | Mark A Wylie Mighty Oak Medical Inc 750 W. Hampden Avenue Suite 120 Englewood, CO 80110 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-10 |
| Decision Date | 2015-12-11 |
| Summary: | summary |