Clearance Summary
STUART CD UNIVERSAL ROD CONNECTOR CLAMPS received FDA 510(k) clearance under submission number K894702, sponsored by Bio-Medical Prosthetics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1989-10-11.
- Submission: K894702
- Applicant / Sponsor: Bio-Medical Prosthetics
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3050
- Decision date: 1989-10-11
Classification & Regulation
This clearance is catalogued under FDA product code KWP and 21 CFR 888.3050, within the Orthopedic review panel as a Class II device.