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TRAUMACEM™ V+ Injectable Bone Cement

K170802 Class II Traditional
Decision Date
2017-09-28
Sponsor / Applicant
Synthes (USA) Products, LLC

Technical Specification

510(k) Submission ID K170802
Product Code LOD
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3027
Decision Date 2017-09-28
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

TRAUMACEM™ V+ Injectable Bone Cement received FDA 510(k) clearance under submission number K170802, sponsored by Synthes (USA) Products, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2017-09-28.

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.