510(k) K161028 ยท PGM Growing Rod System
K2M Growing Spine System
| Applicant | K2m, Inc., Leesburg VA, US |
| Decision | Substantially Equivalent, Jul 22, 2016 |
| Received | Apr 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161028
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.