Clearance Summary
ORTHOFIX received FDA 510(k) clearance under submission number K831576, sponsored by Electro-Biology, Inc.. 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: K831576
- Applicant / Sponsor: Electro-Biology, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 1983-06-08
Classification & Regulation
This clearance is catalogued under FDA product code JEC and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.