510(k) K161032 · NKG Posterior Cervical Screw System
neon3 universal OCT spinal stabilization
| Applicant | Ulrich GmbH & Co. KG, Ulm, DE |
| Decision | Substantially Equivalent, Dec 22, 2016 |
| Received | Apr 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161032
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2019 | ulrich medical USA Inc ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct. Terminated |
LXL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.