510(k) K152237 ยท OUR Sacroiliac Joint Fixation
The Entasis Dual-Lead Sacroiliac Implant
| Applicant | Corelink, LLC, St.Louis MO, US |
| Decision | Substantially Equivalent, Feb 4, 2016 |
| Received | Aug 10, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152237
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.