510(k) K231483
- Device
- MySpine Unilateral Guides
- Applicant
- Medacta International S.A.
- 510(k) number
- K231483
- Product code
- PQC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-07-21
- Date received
- 2023-05-23
- Regulation
- 888.3070
- Classification name
- Pedicle Screw Placement Guide
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Stefano Baj
- Address
- Strada Regina Castel San Pietro CH 6874 6874
FDA Registration Numbers#
- 3011818499
- 8043792
- 3006017180
- 3008110533
- 9681465
- 3005180920
Source Documents#
Other 510(k) Records For Product Code PQC#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253472 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical | 2026-02-25 |
| K203673 | MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides) | Medacta International S.A. | 2021-04-06 |
| K200792 | MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides | Medacta Inernational SA | 2020-10-05 |
| K181883 | FIREFLY® Midline Navigation Guide | Mighty Oak Medical, Inc. | 2018-10-03 |
| K181399 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2018-07-24 |
| K173472 | MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments | Medacta International S.A. | 2018-04-19 |
| K162419 | FIREFLY® Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2016-10-28 |