Clearance Summary
EMS SWISS ORTHOCLAST CHISELS FOR NON-CEMENTED PROSTHESIS REMOVAL received FDA 510(k) clearance under submission number K002484, sponsored by Electro Medical Systems SA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2000-10-04.
- Submission: K002484
- Applicant / Sponsor: Electro Medical Systems SA
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.4580
- Decision date: 2000-10-04
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.