510(k) K111132 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
GENESYS SPINE ANTERIOR CERVICAL PLATE SYSTEM
| Applicant | Genesys Spine, Austin TX, US |
| Decision | Substantially Equivalent, Dec 9, 2011 |
| Received | Apr 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111132
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 8, 2013 | Genesys Orthopedic Systems, LLC 3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System
Product Usage: is intended for anterior screw fixation to the cervical spine. Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.