510(k) K142838 ยท NKG Posterior Cervical Screw System
Synapse Occipital-Cervical-Thoracic (OCT) System
| Applicant | Synthes USA Products, LLC, Raynham MA, US |
| Decision | Substantially Equivalent, Jan 20, 2015 |
| Received | Sep 30, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142838
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2019 | Synthes (USA) Products LLC Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026
for use in spinal surgery Terminated |
NKG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.