510(k) K153326 ยท NKB Thoracolumbosacral Pedicle Screw System
Erisma-LP Spinal Fixation System
| Applicant | Clariance, Sas, Beaurains, FR |
| Decision | Substantially Equivalent, Mar 8, 2016 |
| Received | Nov 19, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153326
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2019 | Clariance Inc Erisma- LP posterior fixation system with the below specifically affected products:
1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths);
2. Erisma-LP Screwdriver; Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.