510(k) K100243 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
QUINTEX CERVICAL PLATING SYSTEM
| Applicant | Aesculap Implant Systems, LLC, Center Valley PA, US |
| Decision | Substantially Equivalent, Sep 2, 2010 |
| Received | Jan 27, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100243
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2012 | Aesculap Implant Systems Quintex Cervical Plating System - Screws. The Quintex Cervical Plating System is intended for the treatment of cervical spinal instability. The Quintex Cervical Screws are available in three different Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.