meddevicedb.com FDA Device Reference

CONFIDENCE HIGH VISCOSITY BONE CEMENT

K060300 Class II Traditional
Decision Date
2006-06-21
Sponsor / Applicant
Disc-O-Tech Medical Technologies, Ltd.

Technical Specification

510(k) Submission ID K060300
Product Code NDN
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3027
Decision Date 2006-06-21
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

CONFIDENCE HIGH VISCOSITY BONE CEMENT received FDA 510(k) clearance under submission number K060300, sponsored by Disc-O-Tech Medical Technologies, 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 2006-06-21.

Classification & Regulation

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