The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc with the FDA for Anteralign(tm) Spinal System With Titan Nanolock Surface Technology Navigated Instruments.
| Device ID | K221180 |
| 510k Number | K221180 |
| Device Name: | Anteralign(TM) Spinal System With Titan NanoLOCK Surface Technology Navigated Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Medtronic Sofamor Danek USA, INC 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Elizabeth Hamilton |
| Correspondent | Elizabeth Hamilton Medtronic Sofamor Danek USA, INC 1800 Pyramid Place Memphis, TN 38132 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-25 |
| Decision Date | 2022-05-25 |