510(k) K032855 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
STRYKER SPINE MAPS SYSTEM
| Applicant | Howmedica Osteonics, Allendale NJ, US |
| Decision | Substantially Equivalent, Dec 10, 2003 |
| Received | Sep 12, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032855
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2009 | Stryker Spine Stryker Trio Connector Hex Socket for Torque Wrench 3.5MM
Not Sterile:
Manufactured by: Stryker Spine SAS, Cestas, France;
Distributed in the USA by: Stryker Spine, Allendale, NJ 07401
The Trio 3.5MM Terminated |
MNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.