510(k) K133556 ยท KWP Appliance, Fixation, Spinal Interlaminal
VIRAGE OCT SPINAL FIXATION SYSTEM
| Applicant | Zimmer Spine, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Jun 2, 2014 |
| Received | Nov 19, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133556
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2016 | Zimmer Spine, Inc. Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3). Terminated |
KWP | None listed |
| Nov 17, 2015 | Zimmer Biomet, Inc. Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3).
UDI Numb Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.