510(k) K133245 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEM
| Applicant | Genesys Spine, Austin TX, US |
| Decision | Substantially Equivalent, Oct 8, 2014 |
| Received | Oct 22, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133245
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2015 | Genesys Orthopedics Systems, LLC Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System
The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation Terminated |
LRZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.