510(k) K153695 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Biomet Spine Fusion System
| Applicant | Biomet Spine, LLC, Broomfield CO, US |
| Decision | Substantially Equivalent, Jan 21, 2016 |
| Received | Dec 23, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153695
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2016 | Zimmer Biomet Spine, Inc Zyston Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile. Terminated |
MAX | None listed |
| Jun 30, 2016 | Zimmer Biomet Spine, Inc Zyston Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile. Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.