510(k) K062698 ยท MNI Orthosis, Spinal Pedicle Fixation
TRIO + SPINAL SYSTEM
| Applicant | Stryker Spine, Allendale NJ, US |
| Decision | Substantially Equivalent, Oct 11, 2006 |
| Received | Sep 11, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062698
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2012 | Stryker Spine The Instructions For Use for the following:
Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW
Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW
Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW
Stryker TRIO+ 5.5 Terminated |
MNI | None listed |
| 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.