510(k) K061813 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
MANTIS SPINAL SYSTEM
| Applicant | Stryker Spine, Allendale NJ, US |
| Decision | Substantially Equivalent, Sep 19, 2006 |
| Received | Jun 27, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061813
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2009 | Stryker Spine Stryker Mantis Rod Inserter; Non Sterile, Manufactured by Stryker Spine SAS, Cestas, France. Distributed by Howmedica Osteonics Corp; 325 Corporate Drive, Mahwah, NJ 07430.
The MANTIS Spinal System Terminated |
MNH | None listed |
| Jul 7, 2009 | Stryker Spine Stryker Mantis Rod Inserter Inner Shaft; Non Sterile; Manufactured by Stryker Spine SAS, Cestas France. Distributed by Stryker Spine, Allendale, NJ 07401-1677.
The MANTIS Spinal System is intended f Terminated |
MNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.