510(k) K113027 ยท OWB Interventional Fluoroscopic X-Ray System
SYNGO AORTIC VALVEGUIDE SOFTWARE
| Applicant | Siemens Medical Solutions USA, Inc., Mavern PA, US |
| Decision | Substantially Equivalent, Nov 22, 2011 |
| Received | Oct 11, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113027
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2016 | LDR Spine USA, Inc. ROI-A Anterior Delivery Device. Orthopedic manual surgical instrument. Model number: SI-ROIA-0023
Auxiliary instrument used in the ROI-A-ALIR cage system: Spinal intervertbral body fusion device. Terminated |
LXH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.