Clearance Summary
REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CE received FDA 510(k) clearance under submission number K133370, sponsored by Signature Orthopaedics Pty Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2014-07-22.
- Submission: K133370
- Applicant / Sponsor: Signature Orthopaedics Pty Limited
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3358
- Decision date: 2014-07-22
Classification & Regulation
This clearance is catalogued under FDA product code LPH and 21 CFR 888.3358, within the Orthopedic review panel as a Class II device.