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LOADPRO Intraoperative Rod Strain Sensor

by Intellirod Spine, Inc.

De Novo DEN180012

Active United States

De Novo

Valid until

No expiry

De Novo grant is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA De Novo, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA De NovoDENG De Novo granted · Direct NumberDEN180012 Date28 Mar 2019DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA De Novo Active

Specification

De Novo

De Novo Number
FDA Product Code
QFP
Device Class
Class II
Regulation
21 CFR Part 888.3090
Advisory Committee
Orthopedic
FDA Decision
DENG De Novo granted

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The LOADPRO Intraoperative Rod Strain Sensor is an intraoperative surgical tool that allows surgeons to measure unidirectional rod microstrain on posterior rods in the sagittal plane when performing spine surgery. This device is an adjunct to surgeon tactile feedback and is not intended to replace a surgeon's clinical judgment.

The LOADPRO Intraoperative Rod Strain Sensor is a single-use device. It is authorized under FDA 510(k) clearance with product code QFP and device class 2. The device is supplied sterile and is intended for use in orthopedic surgical procedures.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the LOADPRO Intraoperative Rod Strain Sensor used for?

    The LOADPRO Intraoperative Rod Strain Sensor is an intraoperative surgical tool that allows surgeons to measure unidirectional rod microstrain on posterior rods in the sagittal plane during spine surgery. It serves as an adjunct to surgeon tactile feedback and is not intended to replace clinical judgment.

  • Is the LOADPRO sensor reusable or single-use?

    The LOADPRO Intraoperative Rod Strain Sensor is a single-use device. It is supplied sterile and is intended for one-time use during orthopedic surgical procedures. Reusing the device could compromise its accuracy and sterility.

  • What regulatory authorization does the LOADPRO sensor have?

    The LOADPRO Intraoperative Rod Strain Sensor is authorized under FDA 510(k) clearance with product code QFP and device class 2. It received clearance on March 28, 2019, with the designation DEN180012.

  • How is the LOADPRO sensor supplied to medical facilities?

    The LOADPRO Intraoperative Rod Strain Sensor is supplied sterile to medical facilities. It is designed for use in orthopedic surgical procedures where measuring rod microstrain is beneficial for surgical decision-making.