510(k) K161189 ยท PHX Shoulder Prosthesis, Reverse Configuration
Integra TITAN Reverse Shoulder System
| Applicant | Integra LifeSciences Corporation, Austin TX, US |
| Decision | Substantially Equivalent, Aug 25, 2016 |
| Received | Apr 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161189
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.