510(k) K103505 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
ALTUM ANTERIOR CERVICAL PLATE
| Applicant | Spinecraft, LLC, Westchester IL, US |
| Decision | Substantially Equivalent, Mar 15, 2011 |
| Received | Nov 29, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103505
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Siemens Medical Solutions USA, Inc ARTISTE and ONCOR linear accelerators with G31 mother board.
ARTISTE and ONCOR are manufactured by Siemens Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany.
ARTISTE, ONCOR and PRIMUS famil Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.