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Cellent Spinal Systems

K172826 Class II Traditional
Decision Date
2018-10-10
Sponsor / Applicant
Jiangsu Trauhui Medical Instrument Co., Ltd.

Technical Specification

510(k) Submission ID K172826
Product Code NKB
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3070
Decision Date 2018-10-10
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Cellent Spinal Systems received FDA 510(k) clearance under submission number K172826, sponsored by Jiangsu Trauhui Medical Instrument Co., 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 2018-10-10.

Classification & Regulation

This clearance is catalogued under FDA product code NKB and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.