Pedicle Screw Placement Guide
The Pedicle Screw Placement Guide is a surgical instrument used intraoperatively to assist in the accurate placement of pedicle screws that anchor spinal systems onto the posterior elements of the spine, utilizing anatomic landmarks identifiable on pre-operative imaging scans. It is classified as FDA Class 2 under 21 CFR 888.3070 in the Orthopedic specialty, requiring 510(k) premarket notification. The device improves precision during spinal surgery. Product code PQC; not an implant and not life-sustaining.
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Basic Information
- Product Code
- PQC
- Device Class
- FDA class 2
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253472 | FIREFLY® Pedicle Screw Navigation Guide | Feb 25, 2026 | Substantially Equivalent | Mighty Oak Medical |
| K231483 | MySpine Unilateral Guides | Jul 21, 2023 | Substantially Equivalent | Medacta International S.A. |
| K203673 | MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides) | Apr 06, 2021 | Substantially Equivalent | Medacta International S.A. |
| K200792 | MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides | Oct 05, 2020 | Substantially Equivalent | Medacta Inernational SA |
| K181883 | FIREFLY® Midline Navigation Guide | Oct 03, 2018 | Substantially Equivalent | Mighty Oak Medical, Inc. |
| K181399 | FIREFLY® Pedicle Screw Navigation Guide | Jul 24, 2018 | Substantially Equivalent | Mighty Oak Medical, Inc. |
| K173472 | MySpine Pedicle Screw Placement Guides MC and Drill Pilot Instruments | Apr 19, 2018 | Substantially Equivalent | Medacta International S.A. |
| K162419 | FIREFLY® Pedicle Screw Navigation Guide | Oct 28, 2016 | Substantially Equivalent | Mighty Oak Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.