PQC — Pedicle Screw Placement Guide Class II
Classification Details
- Product Code
- PQC
- Device Class
- Class II
- Regulation Number
- 888.3070
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253472 | mighty oak medical | FIREFLY® Pedicle Screw Navigation Guide | February 25, 2026 |
| K231483 | medacta international | MySpine Unilateral Guides | July 21, 2023 |
| K203673 | medacta international | MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, My | April 6, 2021 |
| K200792 | medacta inernational | MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides | October 5, 2020 |
| K181883 | mighty oak medical | FIREFLY® Midline Navigation Guide | October 3, 2018 |
| K181399 | mighty oak medical | FIREFLY® Pedicle Screw Navigation Guide | July 24, 2018 |
| K173472 | medacta international | MySpine Pedicle Screw Placement Guides MC and Drill Pilot Instruments | April 19, 2018 |
| K162419 | mighty oak medical | FIREFLY® Pedicle Screw Navigation Guide | October 28, 2016 |