K231515 is an FDA 510(k) clearance for the MySpine Cervical Guides. This device is classified as a Posterior Cervical Screw Placement Guide (Class II - Special Controls, product code QSD).
Submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on December 7, 2023, 196 days after receiving the submission on May 25, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3075. A Posterior Cervical Screw Placement Guide Is Intended To Be Used As A Surgical Instrument To Assist In The Intra-operative Placement Of Posterior Cervical Screws That Are Used To Anchor Posterior Cervical Screw Systems On The Posterior Elements Of The Spine. The Device Utilizes Anatomic Landmarks That Are Identifiable On Pre-operative Imaging Scans..
| 510(k) Number | K231515 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 25, 2023 |
| Decision Date | December 07, 2023 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | QSD — Posterior Cervical Screw Placement Guide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3075 |
| Definition | A Posterior Cervical Screw Placement Guide Is Intended To Be Used As A Surgical Instrument To Assist In The Intra-operative Placement Of Posterior Cervical Screws That Are Used To Anchor Posterior Cervical Screw Systems On The Posterior Elements Of The Spine. The Device Utilizes Anatomic Landmarks That Are Identifiable On Pre-operative Imaging Scans. |