510(k) K040261 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM
| Applicant | Stryker Spine, Allendale NJ, US |
| Decision | Substantially Equivalent, Apr 16, 2004 |
| Received | Feb 4, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040261
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 20, 2009 | Stryker Spine Stryker Reflex Hybrid Level Anterior Cervical Plate;
Non Sterile; Manufactured by Stryker Spine SAS, Cestas, France. Distributed by Howmedica Osteonics Corp. Mahwah, NJ 07430. Terminated |
KWQ | None listed |
| Aug 20, 2009 | Stryker Spine Stryker Reflex Hybrid variable self-drilling screw.
Non Sterile.
Manufactured by Stryker Spine SAS, Cestas, France.
Distributed in USA by Howmedica Osteonics Corp., Mahwah, NJ 07430. Terminated |
KWQ | None listed |
| Aug 20, 2009 | Stryker Spine Stryker Reflex Hybrid Variable Self-Tapping Screw.
Non Sterile. Manufactured by Stryker Spine, SAS, Cestas, France. Distributed in USA by Howmedica Osteonics, Mahwah, NJ 07430. Terminated |
KWQ | None listed |
| Nov 20, 2008 | Stryker Spine Reflex Hybrid 4.0 x 14 mm Variable, Self-Tapping Bone Screw (Non- sterile).
Manufactured by Stryker Spine SAS, Cestas, France. Distributed in USA by Howmedica Osteonics, Mahwah, NJ.
The bone screw (R Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.