510(k) K093670 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
MODIFICATION TO: OASYS SYSTEM
| Applicant | Stryker Spine, Allendale NJ, US |
| Decision | Substantially Equivalent, Mar 18, 2010 |
| Received | Nov 27, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093670
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2013 | Stryker Spine Stryker Oasys Midline Occiput Plate-1) Small 2) Medium 3) Large 4) Large Long
5) Mini.
Allows for positioning directly on the midline keel of the occiput. Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.