510(k) K142101 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
ABACUS (TM) SPACER SYSTEM
| Applicant | Spine Wave, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Oct 23, 2014 |
| Received | Aug 1, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142101
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.