510(k) K052971 ยท MNI Orthosis, Spinal Pedicle Fixation
STRYKER SPINE TRIO SPINAL FIXATION SYSTEM
| Applicant | Stryker Spine, Allendale NJ, US |
| Decision | Substantially Equivalent, Nov 16, 2005 |
| Received | Oct 24, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052971
| 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 |
| Apr 10, 2009 | Stryker Spine Stryker Trio Small Offset Connector
Non Sterile; Manufactured by Stryker Spine SAS, Z.I. Marticot -33610- Cestas, France. Distributed in USA by Howmedica Osteonics Corp., Mahwah, NJ.
The Trio Spinal Terminated |
MNI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.