Medtronic Sofamor Danek USA, Inc. · Class II · Cleared May 26, 2021
| K-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 System, Endoskeleton TT Interbody System |
| Applicant | Medtronic Sofamor Danek USA, Inc. |
| Product code | MAX |
| Device class | Class II |
| Decision date | May 26, 2021 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
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