Clearance Summary
JURGAN PIN BALL received FDA 510(k) clearance under submission number K831072, sponsored by Jurgan Development & Mfg., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1983-06-08.
- Submission: K831072
- Applicant / Sponsor: Jurgan Development & Mfg., Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 1983-06-08
Classification & Regulation
This clearance is catalogued under FDA product code LYT and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.