510(k) K141798 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
SYPHER SPACER SYSTEM
| Applicant | Biogennix, LLC, Colorado Springs CO, US |
| Decision | Substantially Equivalent, Feb 19, 2015 |
| Received | Jul 3, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141798
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.