LOADPRO Intraoperative Rod Strain Sensor— 510(k) DEN180012

Name: FDA 510(k) clearance DEN180012
Creator: U.S. Food and Drug Administration
Published: 2019-03-28

Unknown

Intellirod Spine, Inc.

FDA 510(k) clearance DEN180012 for LOADPRO Intraoperative Rod Strain Sensor, Unknown on 2019-03-28. Applicant: Intellirod Spine, Inc.. Device class: 2.

Clearance details

Applicant: Intellirod Spine, Inc.
Product code: Code QFP
Device class: Class 2
Regulation: 21 CFR 888.3090
Advisory panel: Orthopedic
Date received: 2018-03-14
Decision date: 2019-03-28
Decision: Unknown
Clearance type: Direct
Location: Akron, OH, US

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