Clearance Summary
EBI X FIX DYNAFIX SYSTEM/EBI DFS DISTAL RADIUS FIXATOR SC BONE SCREWS received FDA 510(k) clearance under submission number K961433, 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 1996-06-28.
- Submission: K961433
- Applicant / Sponsor: Electro-Biology, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 1996-06-28
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.