Clearance Summary
ARTHROBOT 100 UPPER LIMB POSITIONER received FDA 510(k) clearance under submission number K873079, sponsored by Andronic Devices, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1987-11-25.
- Submission: K873079
- Applicant / Sponsor: Andronic Devices, Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4960
- Decision date: 1987-11-25
Classification & Regulation
This clearance is catalogued under FDA product code JEA and 21 CFR 878.4960, within the General, Plastic Surgery review panel as a Class I device.