Clearance Summary
VIRTU Lumbar Spacer System received FDA 510(k) clearance under submission number K160699, 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 2016-08-01.
- Submission: K160699
- Applicant / Sponsor: Met 1 Technologies, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2016-08-01
Classification & Regulation
This clearance is catalogued under FDA product code MAX and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.