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LOADPRO™ Intraoperative Rod Strain Sensor

DEN180012 Class II Direct
Decision Date
2019-03-28
Sponsor / Applicant
Intellirod Spine, Inc.

Technical Specification

510(k) Submission ID DEN180012
Product Code QFP
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3090
Decision Date 2019-03-28
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

LOADPRO™ Intraoperative Rod Strain Sensor received FDA 510(k) clearance under submission number DEN180012, sponsored by Intellirod Spine, 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 2019-03-28.

Classification & Regulation

This clearance is catalogued under FDA product code QFP and 21 CFR 888.3090, within the Orthopedic review panel as a Class II device.