meddevicedb.com FDA Device Reference

ACRON™ TLIF System

K171151 Class II Traditional
Decision Date
2018-04-27
Sponsor / Applicant
Spinemed Ges.M.B.H

Technical Specification

510(k) Submission ID K171151
Product Code MAX
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3080
Decision Date 2018-04-27
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

ACRON™ TLIF System received FDA 510(k) clearance under submission number K171151, sponsored by Spinemed Ges.M.B.H. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2018-04-27.

Classification & Regulation

This clearance is catalogued under FDA product code MAX and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.