Clearance Summary
Virtu C Spinal Implant System received FDA 510(k) clearance under submission number K161649, sponsored by Met 1 Technologies, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2016-11-09.
- Submission: K161649
- Applicant / Sponsor: Met 1 Technologies, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2016-11-09
Classification & Regulation
This clearance is catalogued under FDA product code ODP and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.