Clearance Summary
ESKA-LIBUR HIP STEM received FDA 510(k) clearance under submission number K053557, sponsored by Eska Implants GmbH & Co.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2006-01-20.
- Submission: K053557
- Applicant / Sponsor: Eska Implants GmbH & Co.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3358
- Decision date: 2006-01-20
Classification & Regulation
This clearance is catalogued under FDA product code LPH and 21 CFR 888.3358, within the Orthopedic review panel as a Class II device.