Clearance Summary
40-42mm BiPolar Head and 22mm Femoral Head received FDA 510(k) clearance under submission number K163081, sponsored by Signature Orthopaedics Pty, 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 2018-01-29.
- Submission: K163081
- Applicant / Sponsor: Signature Orthopaedics Pty, Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3390
- Decision date: 2018-01-29
Classification & Regulation
This clearance is catalogued under FDA product code KWY and 21 CFR 888.3390, within the Orthopedic review panel as a Class II device.