Clearance Summary
Piccolo Composite(R) Distal Volar Radius Plate System received FDA 510(k) clearance under submission number K160002, sponsored by CarboFix Orthopedics , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2016-03-09.
- Submission: K160002
- Applicant / Sponsor: CarboFix Orthopedics , Ltd.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2016-03-09
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.