Clearance Summary
TRAPEZIO-METACARPAL JOINT SPACER received FDA 510(k) clearance under submission number K790508, sponsored by Scientific Data Systems Israel, 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 1979-04-10.
- Submission: K790508
- Applicant / Sponsor: Scientific Data Systems Israel, Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3770
- Decision date: 1979-04-10
Classification & Regulation
This clearance is catalogued under FDA product code KYI and 21 CFR 888.3770, within the Orthopedic review panel as a Class II device.