FIREFLY® Pedicle Screw Navigation Guide
FDA 510(k) K253472 · Mighty Oak Medical
510(k) numberK253472
Submission
- Device name
- FIREFLY® Pedicle Screw Navigation Guide
- Applicant
- Mighty Oak Medical
Englewood, CO, US - Received
- October 10, 2025
- Decision date
- February 25, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PQC – Pedicle Screw Placement Guide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
A pedicle screw placement guide is intended to be used as a surgical instrument to assist in the intra-operative placement of pedicle screws that are used to anchor pedicle screw spinal systems onto the posterior elements of the spine. The device utilizes anatomic landmarks that are identifiable on pre-operative imaging scans.
Other 510(k)s with product code PQC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K231483 | MySpine Unilateral GuidesPQC · Traditional | Medacta International S.A. | 07/21/2023SE |
| K203673 | MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…PQC · Special | Medacta International S.A. | 04/06/2021SE |
| K200792 | MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesPQC · Traditional | Medacta Inernational SA | 10/05/2020SE |
| K181883 | FIREFLY® Midline Navigation GuidePQC · Traditional | Mighty Oak Medical, Inc. | 10/03/2018SE |
| K181399 | FIREFLY® Pedicle Screw Navigation GuidePQC · Traditional | Mighty Oak Medical, Inc. | 07/24/2018SE |
| K173472 | MySpine Pedicle Screw Placement Guides MC and Drill Pilot InstrumentsPQC · Traditional | Medacta International S.A. | 04/19/2018SE |
| K162419 | FIREFLY® Pedicle Screw Navigation GuidePQC · Traditional | Mighty Oak Medical, Inc. | 10/28/2016SE |
More from Mighty Oak Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260322 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)QIH · Traditional | 06/11/2026SE |
| K252103 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)QIH · Traditional | 12/02/2025SE |
| K251532 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)LLZ · Traditional | 11/03/2025SE |
| K234009 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)QIH · Traditional | 07/12/2024SE |
| K220132 | FIREFLY® Cervical Navigation GuideQSD · Traditional | 10/26/2022SE |
| K181883 | FIREFLY® Midline Navigation GuidePQC · Traditional | 10/03/2018SE |
| K181399 | FIREFLY® Pedicle Screw Navigation GuidePQC · Traditional | 07/24/2018SE |
| K162419 | FIREFLY® Pedicle Screw Navigation GuidePQC · Traditional | 10/28/2016SE |
| K143222 | FIREFLY Pedicle Screw Navigation GuideMNI · Traditional | 12/11/2015SE |
Questions and answers
When was FIREFLY® Pedicle Screw Navigation Guide cleared by the FDA?
FIREFLY® Pedicle Screw Navigation Guide (K253472) received a 510(k) decision of Substantially Equivalent on February 25, 2026, 138 days after the submission was received.
What is the product code of K253472?
The FDA product code is PQC – Pedicle Screw Placement Guide, a Class II (moderate risk) device regulated under 21 CFR 888.3070.