Clearance Summary
LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) received FDA 510(k) clearance under submission number K072961, sponsored by Sra Developments, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2007-12-19.
- Submission: K072961
- Applicant / Sponsor: Sra Developments, Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.4580
- Decision date: 2007-12-19
Classification & Regulation
This clearance is catalogued under FDA product code JDX and 21 CFR 888.4580, within the Orthopedic review panel as a Class II device.