K153273 is an FDA 510(k) clearance for the MySpine Pedicle Screw Placement Guides - LP. This device is classified as a Orthosis, Spinal Pedicle Fixation (Class II - Special Controls, product code MNI).
Submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on June 29, 2016, 230 days after receiving the submission on November 12, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070.
| 510(k) Number | K153273 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2015 |
| Decision Date | June 29, 2016 |
| Days to Decision | 230 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MNI — Orthosis, Spinal Pedicle Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |