| Primary Device ID | 00763000193935 |
| NIH Device Record Key | 1fe4c204-11fc-4f0c-99bb-4b9ae3d95f7f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Anteralign Spinal System with Titan nanoLock Surface technology |
| Version Model Number | 4680004 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000193935 [Primary] |
| MAX | Intervertebral fusion device with bone graft, lumbar |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
[00763000193935]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-03 |
| Device Publish Date | 2021-12-26 |
| 00763000198589 | TRIAL 46813420 24DG 23W 20X60MM |
| 00763000198473 | TRIAL 46813614 6DG 23W 14X60MM |
| 00763000193942 | INSERTER 4680005 INTERBODY/TRIAL SHAFT |
| 00763000193935 | INSERTER 4680004 INTERBODY/TRIAL |
| 00763000193881 | TRIAL 46813416 24DG 23W 16X60MM |
| 00763000193874 | TRIAL 46813414 24DG 23W 14X60MM |
| 00763000193867 | TRIAL 46813816 18DG 23W 16X60MM |
| 00763000193850 | TRIAL 46813814 18DG 23W 14X60MM |
| 00763000193843 | TRIAL 46813812 18DG 23W 12X60MM |
| 00763000193836 | TRIAL 46813214 12DG 23W 14X60MM |
| 00763000193829 | TRIAL 46813212 12DG 23W 12X60MM |
| 00763000193812 | TRIAL 46813210 12DG 23W 10X60MM |
| 00763000193805 | TRIAL 46813612 6DG 23W 12X60MM |
| 00763000193799 | TRIAL 46813610 6DG 23W 10X60MM |
| 00763000193782 | TRIAL 46813608 6DG 23W 8X60MM |
| 00763000193775 | TRIAL 46812214 12DG 20W 14X60MM |
| 00763000193768 | TRIAL 46812212 12DG 20W 12X60MM |
| 00763000193751 | TRIAL 46812210 12DG 20W 10X60MM |
| 00763000193744 | TRIAL 46812614 6DG 20W 14X60MM |
| 00763000193737 | TRIAL 46812612 6DG 20W 12X60MM |
| 00763000193720 | TRIAL 46812610 6DG 20W 10X60MM |
| 00763000193713 | TRIAL 46812608 6DG 20W 8X60MM |
| 00763000194000 | BLOCK 4680011 LOADING BLOCK |
| 00763000193997 | DRIVER 4680010 T20 LONG SCREWDRIVER |
| 00763000193980 | DRIVER 4680009 T20 SCREWDRIVER |
| 00763000193973 | DRIVER 4680008 T20 BALLJOINT DRIVER |
| 00763000193966 | INSERTER 4680007 MINIPLATE SHAFT |
| 00763000193959 | INSERTER 4680006 MINIPLATE INSERTER |
| 00763000198572 | TRIAL 46813418 24DG 23W 18X60MM |
| 00763000198565 | TRIAL 46812420 24DG 20W 20X60MM |
| 00763000198558 | TRIAL 46812418 24DG 20W 18X60MM |
| 00763000198541 | TRIAL 46812416 24DG 20W 16X60MM |
| 00763000198534 | TRIAL 46812414 24DG 20W 14X60MM |
| 00763000198527 | TRIAL 46813820 18DG 23W 20X60MM |
| 00763000198510 | TRIAL 46813818 18DG 23W 18X60MM |
| 00763000198503 | TRIAL 46813218 12DG 23W 18X60MM |
| 00763000198497 | TRIAL 46813216 12DG 23W 16X60MM |
| 00763000198480 | TRIAL 46813616 6DG 23W 16X60MM |
| 00763000198466 | TRIAL 46812820 18DG 20W 20X60MM |
| 00763000198459 | TRIAL 46812818 18DG 20W 18X60MM |
| 00763000198442 | TRIAL 46812816 18DG 20W 16X60MM |
| 00763000198435 | TRIAL 46812814 18DG 20W 14X60MM |
| 00763000198428 | TRIAL 46812812 18DG 20W 12X60MM |
| 00763000198411 | TRIAL 46812218 12DG 20W 18X60MM |
| 00763000198404 | TRIAL 46812216 12DG 20W 16X60MM |
| 00763000198398 | TRIAL 46812616 6DG 20W 16X60MM |
| 00763000128326 | NANO SPACER 46381845 TI 18DG 23W 18X45MM |
| 00763000128302 | NANO SPACER 46381660 TI 18DG 23W 16X60MM |
| 00763000194024 | SLAPHAMMER 4680013 DUAL-ENDED SLAPHAMMER |
| 00763000193928 | AWL 4680003 STRAIGHT AWL SHAFT |