510(k) DEN180012
- Device
- LOADPRO? Intraoperative Rod Strain Sensor
- Applicant
- Intellirod Spine, Inc.
- 510(k) number
- DEN180012
- Product code
- QFP
- Decision
- Unknown (DENG)
- Decision date
- 2019-03-28
- Date received
- 2018-03-14
- Regulation
- 888.3090
- Classification name
- Intraoperative Orthopedic Strain Sensor
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- No
Applicant Contact#
- Contact
- Richard R. Navarro
- Address
- 554f White Pond Dr. Akron OH US 44320 44320
Source Documents#
510(k) summary PDF not indicated by FDA