510(k) DEN180012
DEN180012 is an FDA 510(k) premarket notification submitted by Intellirod Spine, Inc. for the device "LOADPRO Intraoperative Rod Strain Sensor". The FDA issued a decision of De Novo Granted on March 28, 2019. The device falls under product code QFP (Intraoperative Orthopedic Strain Sensor), a Class II device regulated under 21 CFR 888.3090.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- March 28, 2019
- Date Received
- March 14, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intraoperative Orthopedic Strain Sensor
- Device Class
- Class II
- Regulation Number
- 888.3090
- Review Panel
- OR
- Submission Type
A strain sensor device is an adjunct tool intended to measure strain on an orthopedic implant in the intraoperative setting only. The device is not intended to provide diagnostic information or influence clinical decision-making.