Clearance Summary
MODIFICATION TO ESOP CO-CR FEMORAL HEADS received FDA 510(k) clearance under submission number K023375, sponsored by Pro-Active Healthcare. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2002-10-25.
- Submission: K023375
- Applicant / Sponsor: Pro-Active Healthcare
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3358
- Decision date: 2002-10-25
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.