Clearance Summary
Hi-Fatigue G Bone Cement received FDA 510(k) clearance under submission number K192379, sponsored by Osartis GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2019-11-27.
- Submission: K192379
- Applicant / Sponsor: Osartis GmbH
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3027
- Decision date: 2019-11-27
Classification & Regulation
This clearance is catalogued under FDA product code LOD and 21 CFR 888.3027, within the Orthopedic review panel as a Class II device.