The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Endoskeleton Tc Interbody System, Endoskeleton Tcs Interbody System, Endoskeleton Ta Interbody System, Endoskeleton Tas & Tas Hyp Interbody System, Endoskeleton Tl Interbody System, Endoskeleton Tl Hyp. Interbody System, Endoskeleton To Interbody Sys.
| Device ID | K211258 |
| 510k Number | K211258 |
| Device Name: | Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody Sys |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Kelly Mcdonnell |
| Correspondent | Kelly Mcdonnell Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Product Code | MAX |
| Subsequent Product Code | ODP |
| 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 | 2021-04-26 |
| Decision Date | 2021-05-26 |