510(k) K192018 ยท ODP Intervertebral Fusion Device With Bone Graft, Cervical
Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic 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 Fusi
| Applicant | Titan Spine, Inc., Mequon WI, US |
| Decision | Substantially Equivalent, Aug 16, 2019 |
| Received | Jul 29, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192018
| 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, Small, 8 mm, Product Number 5146-1208-N - Product Usage: indicated to be used with supplemental fixation cleared by t Terminated |
MAX | 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.