510(k) K101288 ยท MQP Spinal Vertebral Body Replacement Device
STAXX XD SYSTEM
| Applicant | Spine Wave, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Sep 10, 2010 |
| Received | May 7, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101288
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2011 | Spine Wave Inc StaXx XD Expandable Cartridge Convex Expandable Implant 25mm (L) x 9mm (W) x 7mm (H)
Catalog number: 11-1525
The StaXx XD System is a vertebral body replacement device intended for use in the thoracol Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.