Clearance Summary
The Progressive Orthopaedic Total Hip System received FDA 510(k) clearance under submission number K151424, sponsored by The Progressive Orthopaedic Company, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2016-07-27.
- Submission: K151424
- Applicant / Sponsor: The Progressive Orthopaedic Company, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3358
- Decision date: 2016-07-27
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.