510(k) K140238 ยท NKB Thoracolumbosacral Pedicle Screw System
EXCELLA III-D SPINAL DEFORMITY SYSTEM
| Applicant | Innovasis, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, May 7, 2014 |
| Received | Jan 30, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140238
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2016 | Innovasis, Inc Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502
Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization Terminated |
NKB | None listed |
| Jul 16, 2014 | Innovasis, Inc Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.