Clearance Summary
MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides) received FDA 510(k) clearance under submission number K203673, sponsored by Medacta International S.A.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2021-04-06.
- Submission: K203673
- Applicant / Sponsor: Medacta International S.A.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2021-04-06
Classification & Regulation
This clearance is catalogued under FDA product code PQC and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.