VERASENSE Knee System
FDA 510(k) clearance K150372 · decided 2016-04-15
Clearance details
- K-number
- K150372
- Device name
- VERASENSE Knee System
- Applicant
- Orthosensor, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-02-13
- Decision date
- 2016-04-15
- Days to decision
- 427 days
- Clearance type
- Traditional
- Product code
- ONN
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Dania Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.