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Duo™ Lumbar Interbody Fusion Device

K181792 Class II Special
Decision Date
2018-08-14
Sponsor / Applicant
Spineology, Inc.

Technical Specification

510(k) Submission ID K181792
Product Code MAX
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3080
Decision Date 2018-08-14
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Duo™ Lumbar Interbody Fusion Device received FDA 510(k) clearance under submission number K181792, sponsored by Spineology, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2018-08-14.

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.