Clearance Summary
ULTIMA TPS CEMENTED STEM received FDA 510(k) clearance under submission number K965198, sponsored by Johnson & Johnson International. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1997-07-23.
- Submission: K965198
- Applicant / Sponsor: Johnson & Johnson International
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3360
- Decision date: 1997-07-23
Classification & Regulation
This clearance is catalogued under FDA product code KWL and 21 CFR 888.3360, within the Orthopedic review panel as a Class II device.