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CONFIDENCE Spinal Cement System

K201831 Class II Traditional
Decision Date
2020-08-31
Sponsor / Applicant
Depuy Spine, Inc.

Technical Specification

510(k) Submission ID K201831
Product Code NDN
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3027
Decision Date 2020-08-31
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

CONFIDENCE Spinal Cement System received FDA 510(k) clearance under submission number K201831, sponsored by Depuy Spine, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2020-08-31.

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.