510(k) K130380 ยท ONN Intraoperative Orthopedic Joint Assessment Aid
ORTHOSENSOR KNEE BALANCER
| Applicant | Orthosensor, Inc., Sunrise FL, US |
| Decision | Substantially Equivalent, Jun 13, 2013 |
| Received | Feb 14, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130380
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 29, 2015 | Orthosensor, Inc. Verasense Knee System, Model SYK-TRCR 02. Intelligent disposable tibial insert that measures dynamic loads during orthopedic knee surgery. Terminated |
ONN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.