Clearance Summary
MOLDED POLYSULFONE TRIAL PROSTHESIS received FDA 510(k) clearance under submission number K811205, sponsored by Shannon Group. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1981-05-21.
- Submission: K811205
- Applicant / Sponsor: Shannon Group
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4800
- Decision date: 1981-05-21
Classification & Regulation
This clearance is catalogued under FDA product code HWT and 21 CFR 888.4800, within the Orthopedic review panel as a Class I device.