510(k) K102090 ยท OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
SPINESMITH CYNCH SPINAL SYSTEM - VISUALIF INTERBODY FUSION IMPLANT SYSTEM
| Applicant | Spine Smith Partners L.P., Austin TX, US |
| Decision | Substantially Equivalent, Sep 30, 2010 |
| Received | Jul 26, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102090
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2013 | Spine Smith Holdings, LLC VisuALIF,System consisting of a 'U' shaped PEEK block in two footprint configurations, four heights and three lordosis angles., part number: 0301-1410.
Intended to be implanted via an open anterior Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.