meddevicedb.com FDA Device Reference

G3 40 Radiopaque Bone Cement

K193061 Class II Traditional
Decision Date
2020-03-19
Sponsor / Applicant
G21, S.R.L.

Technical Specification

510(k) Submission ID K193061
Product Code LOD
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3027
Decision Date 2020-03-19
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

G3 40 Radiopaque Bone Cement received FDA 510(k) clearance under submission number K193061, sponsored by G21, S.R.L.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2020-03-19.

Classification & Regulation

This clearance is catalogued under FDA product code LOD and 21 CFR 888.3027, within the Orthopedic review panel as a Class II device.