510(k) K102853 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
FLAMENCO SPINAL FIXATION SYSTEM
| Applicant | Ulrich GmbH & Co. KG, St. Louis MO, US |
| Decision | Substantially Equivalent, Jan 25, 2011 |
| Received | Sep 29, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102853
| 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.