510(k) K110604 ยท NDN Cement, Bone, Vertebroplasty
VBB SYSTEM
| Applicant | Synthes, West Chester PA, US |
| Decision | Substantially Equivalent, Dec 13, 2011 |
| Received | Mar 3, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110604
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2014 | PEROUSE MEDICAL Synthes Inflation System (03.804.4135)
Product Usage:
Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressu Terminated |
MAV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.