Clearance Summary
T2 STRATOSPHERE Expandable Corpectomy System received FDA 510(k) clearance under submission number K181328, sponsored by Medtronic Sofamor Danek USA, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2018-09-19.
- Submission: K181328
- Applicant / Sponsor: Medtronic Sofamor Danek USA, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2018-09-19
Classification & Regulation
This clearance is catalogued under FDA product code MQP and 21 CFR 888.3060, within the Orthopedic review panel as a Class II device.