PQC
8 FDA 510(k) clearances · Product code
111 daysmedian time to decision
193 days90th percentile
8clearances measured
FDA profile
- Official device name
- Pedicle Screw Placement Guide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Medical specialty
- Orthopedic
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FIREFLY® Pedicle Screw Navigation Guide (K253472) | Mighty Oak Medical | 2026-02-25 |
| 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 |
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Every clearance here is in the API, with alerts when new ones post.