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 | K192336 |
| 510k Number | K192336 |
| Device Name: | Navigated Anterolateral Disc Prep Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Parwinder Singh |
| Correspondent | Parwinder Singh Medtronic Sofamor Danek USA, INC. 1800 Pyramid Place Memphis, TN 38132 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-28 |
| Decision Date | 2019-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000252021 | K192336 | 000 |
| 00763000200787 | K192336 | 000 |
| 00763000200794 | K192336 | 000 |
| 00763000200800 | K192336 | 000 |
| 00763000200817 | K192336 | 000 |
| 00763000200824 | K192336 | 000 |
| 00763000200831 | K192336 | 000 |
| 00763000200848 | K192336 | 000 |
| 00763000200862 | K192336 | 000 |
| 00763000200879 | K192336 | 000 |
| 00763000200886 | K192336 | 000 |
| 00763000200893 | K192336 | 000 |
| 00763000200909 | K192336 | 000 |
| 00763000200916 | K192336 | 000 |
| 00763000200923 | K192336 | 000 |
| 00763000200930 | K192336 | 000 |
| 00763000209728 | K192336 | 000 |
| 00763000226275 | K192336 | 000 |
| 00763000200855 | K192336 | 000 |