ORTHOSENSOR KNEE BALANCER
FDA 510(k) clearance K130380 · decided 2013-06-13
Clearance details
- K-number
- K130380
- Device name
- ORTHOSENSOR KNEE BALANCER
- Applicant
- Orthosensor, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-02-14
- Decision date
- 2013-06-13
- Days to decision
- 119 days
- Clearance type
- Special
- Product code
- ONN
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Sunrise, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measur recall (Z-1029-2015) | Orthosensor, Inc. | 2015-01-29 |