LOADPRO™ Intraoperative Rod Strain Sensor
FDA 510(k) clearance DEN180012 · decided 2019-03-28
Clearance details
- K-number
- DEN180012
- Device name
- LOADPRO™ Intraoperative Rod Strain Sensor
- Applicant
- Intellirod Spine, Inc.
- Decision
- Unknown
- Date received
- 2018-03-14
- Decision date
- 2019-03-28
- Days to decision
- 379 days
- Clearance type
- Direct
- Product code
- QFP
- Device class
- 2
- Regulation number
- 888.3090
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Akron, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.