K220888 is an FDA 510(k) clearance for the MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides. This device is classified as a Sacroiliac Screw Placement Guide (Class II - Special Controls, product code QSR).
Submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on May 24, 2022, 57 days after receiving the submission on March 28, 2022.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040. A Sacroiliac Screw Placement Guide Is Intended To Be Used As A Surgical Instrument To Assist In The Intra-operative Placement Of Sacroiliac Screws Across The Sacroiliac Joint. The Device Utilizes Anatomical Landmarks That Are Identifiable On Pre-operative Imaging Scans..
| 510(k) Number | K220888 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2022 |
| Decision Date | May 24, 2022 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | QSR — Sacroiliac Screw Placement Guide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |
| Definition | A Sacroiliac Screw Placement Guide Is Intended To Be Used As A Surgical Instrument To Assist In The Intra-operative Placement Of Sacroiliac Screws Across The Sacroiliac Joint. The Device Utilizes Anatomical Landmarks That Are Identifiable On Pre-operative Imaging Scans. |