Clearance Summary
Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System received FDA 510(k) clearance under submission number K182007, sponsored by Renovis Surgical Technologies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2018-12-07.
- Submission: K182007
- Applicant / Sponsor: Renovis Surgical Technologies
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2018-12-07
Classification & Regulation
This clearance is catalogued under FDA product code OVD and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.