Clearance Summary
EBI SMALL EXTERNAL FIXATOR (S/E/F/) received FDA 510(k) clearance under submission number K951357, 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 1995-06-21.
- Submission: K951357
- Applicant / Sponsor: Electro-Biology, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 1995-06-21
Classification & Regulation
This clearance is catalogued under FDA product code KTT and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.