The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Navigated Anterolateral Disc Prep Instruments.
| Device ID | K211441 |
| 510k Number | K211441 |
| Device Name: | Navigated Anterolateral Disc Prep Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Alex Underberg |
| Correspondent | Alex Underberg 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 | 2021-05-10 |
| Decision Date | 2021-06-09 |