Clearance Summary
ARTHRO-SURGIMAT-2000 ECU received FDA 510(k) clearance under submission number K990443, sponsored by W.O.M. World of Medicine GmbH. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1999-02-26.
- Submission: K990443
- Applicant / Sponsor: W.O.M. World of Medicine GmbH
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.1100
- Decision date: 1999-02-26
Classification & Regulation
This clearance is catalogued under FDA product code HRX and 21 CFR 888.1100, within the Orthopedic review panel as a Class II device.