510(k) K161996 ยท MQV Filler, Bone Void, Calcium Compound
0.5cc NanoFUSE, 1.0cc NanoFUSE, 2cc NanoFUSE, 5cc NanoFUSE, 10cc NanoFUSE
| Applicant | Amend Surgical, Inc., Alachua FL, US |
| Decision | Substantially Equivalent, Feb 16, 2017 |
| Received | Jul 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161996
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.