FIREFLY® Pedicle Screw Navigation Guide
FDA 510(k) clearance K253472 · decided 2026-02-25
Clearance details
- K-number
- K253472
- Device name
- FIREFLY® Pedicle Screw Navigation Guide
- Applicant
- Mighty Oak Medical
- Decision
- Substantially Equivalent
- Date received
- 2025-10-10
- Decision date
- 2026-02-25
- Days to decision
- 138 days
- Clearance type
- Traditional
- Product code
- PQC
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MySpine Unilateral Guides (K231483) | Medacta International S.A. | 2023-07-21 |
| MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides) (K203673) | Medacta International S.A. | 2021-04-06 |
| MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides (K200792) | Medacta Inernational SA | 2020-10-05 |
| FIREFLY® Midline Navigation Guide (K181883) | Mighty Oak Medical, Inc. | 2018-10-03 |
| FIREFLY® Pedicle Screw Navigation Guide (K181399) | Mighty Oak Medical, Inc. | 2018-07-24 |
| MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments (K173472) | Medacta International S.A. | 2018-04-19 |
| FIREFLY® Pedicle Screw Navigation Guide (K162419) | Mighty Oak Medical, Inc. | 2016-10-28 |
Recalls involving this device
No recalls on record reference this clearance.