Clearance Summary
MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM received FDA 510(k) clearance under submission number K032641, sponsored by Portland Orthopaedics Pty. , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2004-01-20.
- Submission: K032641
- Applicant / Sponsor: Portland Orthopaedics Pty. , Ltd.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3353
- Decision date: 2004-01-20
Classification & Regulation
This clearance is catalogued under FDA product code MEH and 21 CFR 888.3353, within the Orthopedic review panel as a Class II device.