Clearance Summary
REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION received FDA 510(k) clearance under submission number K142135, sponsored by Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2014-08-28.
- Submission: K142135
- Applicant / Sponsor: Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2014-08-28
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.