The following data is part of a premarket notification filed by Titan Spine, Inc with the FDA for 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 Inter.
| Device ID | K192018 |
| 510k Number | K192018 |
| Device Name: | 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 Inter |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Titan Spine, Inc 6140 West Executive Dr., Suite A Mequon, WI 53092 |
| Contact | Jane Rodd |
| Correspondent | Christine Scifert Titan Spine, Inc 6140 West Executive Dr., Suite A Mequon, WI 53092 |
| Product Code | ODP |
| Subsequent Product Code | MAX |
| Subsequent Product Code | OVD |
| Subsequent Product Code | OVE |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-29 |
| Decision Date | 2019-08-16 |