FIREFLY Pedicle Screw Navigation Guide
FDA 510(k) K143222 · Mighty Oak Medical, Inc.
510(k) numberK143222
Submission
- Device name
- FIREFLY Pedicle Screw Navigation Guide
- Applicant
- Mighty Oak Medical, Inc.
Englewood, CO, US - Received
- November 10, 2014
- Decision date
- December 11, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNI – Orthosis, Spinal Pedicle Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MNI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K171497 | Mikron Spinal Fixation SystemMNI · Traditional | Mikron Makina Sanayi Ticaret Co. , Ltd. | 10/12/2017SE |
| K160731 | LumFix Spinal Fixation SytemMNI · Traditional | CG Bio Co., Ltd. | 10/04/2016SE |
| K151458 | Double Medical Universal Spine SystemMNI · Traditional | Double Medical Technology, Inc. | 08/22/2016SE |
| K153273 | MySpine Pedicle Screw Placement Guides - LPMNI · Traditional | Medacta International S.A. | 06/29/2016SE |
| K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemMNI · Special | Spinevision S.A. | 04/04/2016SE |
| K160320 | PremierMNI · Traditional | Shandong Weigao Orthopaedic Device Co., Ltd. | 04/01/2016SE |
| K160003 | Sniper (R) Spine SystemMNI · Traditional | Spine Wave, Inc. | 02/26/2016SE |
| K152324 | YAHUA Spinal SystemMNI · Traditional | Beijing Weigao Yahua Artificial Joint… | 02/01/2016SE |
| K150684 | WASTON General Spinal SystemMNI · Traditional | Changzhou Waston Medical Appliance Co., Ltd. | 11/18/2015SE |
| K152132 | X-spine Pedicle Screw SystemMNI · Traditional | X-Spine Systems, Inc. | 09/25/2015SE |
More from X-Spine Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260322 | Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)QIH · Traditional | 06/11/2026SE |
| K253472 | FIREFLY® Pedicle Screw Navigation GuidePQC · Traditional | 02/25/2026SE |
| 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 |
Questions and answers
When was FIREFLY Pedicle Screw Navigation Guide cleared by the FDA?
FIREFLY Pedicle Screw Navigation Guide (K143222) received a 510(k) decision of Substantially Equivalent on December 11, 2015, 396 days after the submission was received.
What is the product code of K143222?
The FDA product code is MNI – Orthosis, Spinal Pedicle Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.