510(k) K173535 · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device
| Applicant | Titan Spine, LLC, Mequon WI, US |
| Decision | Substantially Equivalent, Feb 13, 2018 |
| Received | Nov 15, 2017 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K173535
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 2, 2021 | Medtronic Sofamor Danek USA Inc Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm Terminated |
OVD | None listed |
| Sep 2, 2021 | Medtronic Sofamor Danek USA Inc Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm Terminated |
OVE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.