510(k) K102248 ยท NKB Thoracolumbosacral Pedicle Screw System
EXCELLA II SPINAL SYSTEM MODEL EC2-00
| Applicant | Innovasis, Inc., Salt Lake City UT, US |
| Decision | Substantially Equivalent, Oct 7, 2010 |
| Received | Aug 9, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102248
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2018 | Innovasis, Inc Excella II Polyaxial Pedicle Screw used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in Terminated |
NKB | None listed |
| 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.