Clearance Summary
CONTOURED ARTICULAR PROSTHESIS (CAP) FEMORAL HEAD RESURFACING SYSTEM received FDA 510(k) clearance under submission number K021549, sponsored by Std Mfg., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2002-08-01.
- Submission: K021549
- Applicant / Sponsor: Std Mfg., Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3400
- Decision date: 2002-08-01
Classification & Regulation
This clearance is catalogued under FDA product code KXA and 21 CFR 888.3400, within the Orthopedic review panel as a Class II device.