510(k) K123717 ยท NKB Thoracolumbosacral Pedicle Screw System
UCENTUM
| Applicant | Ulrich GmbH & Co. KG, Chesterfield MO, US |
| Decision | Unknown, Mar 4, 2013 |
| Received | Dec 4, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123717
| 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.