510(k) K123461 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
STAXX(R) IB SYSTEM
| Applicant | Spine Wave, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Apr 11, 2013 |
| Received | Nov 9, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123461
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2013 | Spine Wave, Inc. StaXx IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902.
Indicated for intervertebral body fusion procedures in skeletally mature patients. Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.