510(k) K081038 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
| Applicant | Medtronic Sofamor Danek, Memphis TN, US |
| Decision | Substantially Equivalent, Aug 15, 2008 |
| Received | Apr 11, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081038
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2012 | Medtronic Sofamor Danek USA Inc ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132.
Orthopedic. Terminated |
KWQ | None listed |
| Oct 10, 2012 | Medtronic Sofamor Danek USA Inc ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132.
Orthopedic.
Th Terminated |
KWQ | None listed |
| Oct 10, 2012 | Medtronic Sofamor Danek USA Inc PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132.
Orthopedic.
This instrument Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.