Clearance Summary
Aurora® Anterior Lumbar Plate Sytstem received FDA 510(k) clearance under submission number K201079, sponsored by Prism Surgical Design Pty , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2020-08-05.
- Submission: K201079
- Applicant / Sponsor: Prism Surgical Design Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2020-08-05
Classification & Regulation
This clearance is catalogued under FDA product code KWQ and 21 CFR 888.3060, within the Orthopedic review panel as a Class II device.