Clearance Summary
Robotic Graft Delivery Instruments received FDA 510(k) clearance under submission number K230716, sponsored by Medtronic Sofamor Danek, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2023-07-18.
- Submission: K230716
- Applicant / Sponsor: Medtronic Sofamor Danek, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4560
- Decision date: 2023-07-18
Classification & Regulation
This clearance is catalogued under FDA product code OLO and 21 CFR 882.4560, within the Neurology review panel as a Class II device.