The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Adaptix Interbody System With Titan Nanolock Surface Technology.
| Device ID | K201267 |
| 510k Number | K201267 |
| Device Name: | Adaptix Interbody System With Titan NanoLOCK Surface Technology |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Diamond Wallace |
| Correspondent | Diamond Wallace Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-12 |
| Decision Date | 2020-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000202859 | K201267 | 000 |
| 00763000202965 | K201267 | 000 |
| 00763000202972 | K201267 | 000 |
| 00763000202989 | K201267 | 000 |
| 00763000202996 | K201267 | 000 |
| 00763000203009 | K201267 | 000 |
| 00763000203016 | K201267 | 000 |
| 00763000203023 | K201267 | 000 |
| 00763000203030 | K201267 | 000 |
| 00763000202958 | K201267 | 000 |
| 00763000202941 | K201267 | 000 |
| 00763000202866 | K201267 | 000 |
| 00763000202873 | K201267 | 000 |
| 00763000202880 | K201267 | 000 |
| 00763000202897 | K201267 | 000 |
| 00763000202903 | K201267 | 000 |
| 00763000202910 | K201267 | 000 |
| 00763000202927 | K201267 | 000 |
| 00763000202934 | K201267 | 000 |
| 00763000203047 | K201267 | 000 |
| 00763000203054 | K201267 | 000 |
| 00763000203061 | K201267 | 000 |
| 00763000203177 | K201267 | 000 |
| 00763000203184 | K201267 | 000 |
| 00763000203191 | K201267 | 000 |
| 00763000203207 | K201267 | 000 |
| 00763000203214 | K201267 | 000 |
| 00763000203221 | K201267 | 000 |
| 00763000203238 | K201267 | 000 |
| 00763000203245 | K201267 | 000 |
| 00763000203160 | K201267 | 000 |
| 00763000203153 | K201267 | 000 |
| 00763000203078 | K201267 | 000 |
| 00763000203085 | K201267 | 000 |
| 00763000203092 | K201267 | 000 |
| 00763000203108 | K201267 | 000 |
| 00763000203115 | K201267 | 000 |
| 00763000203122 | K201267 | 000 |
| 00763000203139 | K201267 | 000 |
| 00763000203146 | K201267 | 000 |
| 00763000203252 | K201267 | 000 |