Clearance Summary
CONFIDENCE High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems received FDA 510(k) clearance under submission number K160879, sponsored by Medos International Sàrl. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2016-12-20.
- Submission: K160879
- Applicant / Sponsor: Medos International Sàrl
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3027
- Decision date: 2016-12-20
Classification & Regulation
This clearance is catalogued under FDA product code PML and 21 CFR 888.3027, within the Orthopedic review panel as a Class II device.