510(k) K183557 · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endo
| Applicant | Titan Spine, Inc., Mequon WI, US |
| Decision | Substantially Equivalent, Feb 11, 2019 |
| Received | Dec 20, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K183557
| 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 |
| Mar 17, 2021 | Medtronic Sofamor Danek USA, Inc Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be used with supplemental fixation cleared by t Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.