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Piccolo Composite Proximal Tibia Plate System

K201917 Class II Traditional
Decision Date
2020-10-08
Sponsor / Applicant
CarboFix Orthopedics , Ltd.

Technical Specification

510(k) Submission ID K201917
Product Code HRS
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3030
Decision Date 2020-10-08
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Piccolo Composite Proximal Tibia Plate System received FDA 510(k) clearance under submission number K201917, sponsored by CarboFix Orthopedics , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2020-10-08.

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.