510(k) K141632 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Dec 4, 2014 |
| Received | Jun 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141632
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 23, 2018 | Medtronic Sofamor Danek USA Inc Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm
Product Appliance, fixation, spinal intervertebral body Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.