Panels › Orthopedic › Product code PQC · Class 2
Pedicle Screw Placement Guide
Regulation 888.3070
1510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PQC
| Company | 510(k)s | Recalls |
|---|---|---|
| Mighty Oak Medical | 4 | 0 |
| Medacta International S.A. | 3 | 0 |
| Medacta Inernational SA | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 25, 2026 | K253472 | FIREFLY® Pedicle Screw Navigation Guide Mighty Oak Medical | PQC |
| Jul 21, 2023 | K231483 | MySpine Unilateral Guides Medacta International S.A., CH | PQC |
| Apr 6, 2021 | K203673 | MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MyS Medacta International S.A., CH | PQC |
| Oct 5, 2020 | K200792 | MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides Medacta Inernational SA, CH | PQC |
| Oct 3, 2018 | K181883 | FIREFLY® Midline Navigation Guide Mighty Oak Medical, Inc. | PQC |
| Jul 24, 2018 | K181399 | FIREFLY® Pedicle Screw Navigation Guide Mighty Oak Medical, Inc. | PQC |
| Apr 19, 2018 | K173472 | MySpine Pedicle Screw Placement Guides MC and Drill Pilot Instruments Medacta International S.A., CH | PQC |
| Oct 28, 2016 | K162419 | FIREFLY® Pedicle Screw Navigation Guide Mighty Oak Medical, Inc. | PQC |
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