Data / Medical devices / Pedicle Screw Placement Guide
Pedicle Screw Placement Guide (PQC): 3 FDA-registered makers in 2 countries
3 establishments in 2 countries are registered with the FDA to make Pedicle Screw Placement Guide (product code PQC, Class 2, 21 CFR 888.3070). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 8 510(k) clearances under this code, the latest on February 25, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PQC
- Device class
- 2
- Regulation
- 888.3070
- Medical specialty
- Orthopedic
Makers by country
| Country | Makers |
|---|---|
| Switzerland | 2 |
| United States | 1 |
Makers of Pedicle Screw Placement Guide
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medacta International SA | Castel San Pietro Ticino, Switzerland | Complaint file establishment, Manufacturer | 4 | July 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| Medacta International SA | Rancate Ticino, Switzerland | Complaint file establishment, Manufacturer | 4 | July 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| Mighty Oak Medical | Englewood, CO, United States | Complaint file establishment, Manufacturer | 3 | October 3, 2018 | 0 | 0 | 0 | api.fda.gov |
Updated February 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.