meddevicedb.com FDA Device Reference

Spineology Interbody Fusion System

DEN200010 Class II Direct
Decision Date
2020-09-18
Sponsor / Applicant
Spineology, Inc.

Technical Specification

510(k) Submission ID DEN200010
Product Code OQB
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3085
Decision Date 2020-09-18
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Spineology Interbody Fusion System received FDA 510(k) clearance under submission number DEN200010, sponsored by Spineology, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2020-09-18.

Classification & Regulation

This clearance is catalogued under FDA product code OQB and 21 CFR 888.3085, within the Orthopedic review panel as a Class II device.