510(k) K161447 ยท MQV Filler, Bone Void, Calcium Compound
HydroSet XT
| Applicant | Orthovita, Inc., Malver PA, US |
| Decision | Substantially Equivalent, Oct 6, 2016 |
| Received | May 25, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161447
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2018 | Howmedica Osteonics Corp. HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE Terminated |
MQV | None listed |
| Nov 15, 2018 | Howmedica Osteonics Corp. HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE Terminated |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.