K231483 is an FDA 510(k) clearance for the MySpine Unilateral Guides. This device is classified as a Pedicle Screw Placement Guide (Class II - Special Controls, product code PQC).
Submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on July 21, 2023, 59 days after receiving the submission on May 23, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070. 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..
| 510(k) Number | K231483 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2023 |
| Decision Date | July 21, 2023 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | PQC — Pedicle Screw Placement Guide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |
| 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. |