Clearance Summary
Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System received FDA 510(k) clearance under submission number K192818, sponsored by Stryker Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2020-03-31.
- Submission: K192818
- Applicant / Sponsor: Stryker Corporation
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3027
- Decision date: 2020-03-31
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.