510(k) K173832 · ODP Intervertebral Fusion Device With Bone Graft, Cervical
InTice-C Porous Ti Cervical Interbody System
| Applicant | X-Spine Systems, Inc., Miamisburg OH, US |
| Decision | Substantially Equivalent, May 17, 2018 |
| Received | Dec 18, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173832
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 30, 2020 | XTANT Medical XTANT Medical, ## mm x ## mm x # mm x # ,Lordotic/Packaged InTice - C, Sterile R, Single Use Only, for the following Reference numbers/ Primary DI Number/Material Grade on Label:
Ref: X098-0106-STR Terminated |
ODP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.