510(k) K161318 ยท GZT Retractor, Self-Retaining, For Neurosurgery
Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems
| Applicant | Tedan Surgical Innovations, LLC, Sugar Land TX, US |
| Decision | Substantially Equivalent, Mar 20, 2017 |
| Received | May 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161318
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.