MySpine Unilateral Guides
FDA 510(k) K231483 · Medacta International S.A.
510(k) numberK231483
Submission
- Device name
- MySpine Unilateral Guides
- Applicant
- Medacta International S.A.
Castel San Pietro, CH - Received
- May 23, 2023
- Decision date
- July 21, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PQC – Pedicle Screw Placement Guide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
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.
Other 510(k)s with product code PQC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253472 | FIREFLY® Pedicle Screw Navigation GuidePQC · Traditional | Mighty Oak Medical | 02/25/2026SE |
| K203673 | MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…PQC · Special | Medacta International S.A. | 04/06/2021SE |
| K200792 | MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesPQC · Traditional | Medacta Inernational SA | 10/05/2020SE |
| K181883 | FIREFLY® Midline Navigation GuidePQC · Traditional | Mighty Oak Medical, Inc. | 10/03/2018SE |
| K181399 | FIREFLY® Pedicle Screw Navigation GuidePQC · Traditional | Mighty Oak Medical, Inc. | 07/24/2018SE |
| K173472 | MySpine Pedicle Screw Placement Guides MC and Drill Pilot InstrumentsPQC · Traditional | Medacta International S.A. | 04/19/2018SE |
| K162419 | FIREFLY® Pedicle Screw Navigation GuidePQC · Traditional | Mighty Oak Medical, Inc. | 10/28/2016SE |
More from Mighty Oak Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253630 | Mpact 3D Metal FoamLPH · Traditional | 08/28/2026SE |
| K254202 | MectaLIF 3D Metal AnteriorOVD · Traditional | 05/05/2026SE |
| K253940 | M.U.S.T. Pedicle Screw System - ExtensionNKB · Traditional | 04/28/2026SE |
| K253328 | GMK 3D Metal Tibial Tray ExtensionMBH · Traditional | 02/26/2026SE |
| K250644 | MSS - Monobloc stemPHX · Traditional | 02/03/2026SE |
| K251043 | Mpact 3D Metal Implants Extension DMLS TechnologyLPH · Traditional | 01/28/2026SE |
| K252847 | NextAR Hip PlatformSBF · Traditional | 01/09/2026SE |
| K242603 | MyPAO SA guidesPBF · Traditional | 11/19/2025SE |
| K250338 | MSS - Humeral reverse liners extensionPHX · Traditional | 10/31/2025SE |
| K250450 | Coated hip implantsLZO · Traditional | 09/19/2025SE |
Questions and answers
When was MySpine Unilateral Guides cleared by the FDA?
MySpine Unilateral Guides (K231483) received a 510(k) decision of Substantially Equivalent on July 21, 2023, 59 days after the submission was received.
What is the product code of K231483?
The FDA product code is PQC – Pedicle Screw Placement Guide, a Class II (moderate risk) device regulated under 21 CFR 888.3070.