| Primary Device ID | 00613994627698 |
| NIH Device Record Key | 3d468f06-5476-49f7-91cd-da85b3b1f05d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | |TSRH® Spinal System |
| Version Model Number | 8351523 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994627698 [Primary] |
| MNH | Orthosis, spondylolisthesis spinal fixation |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-06-26 |
| 00643169281165 - CD HORIZON® ASTUTE™ SPINAL SYSTEM | 2024-05-27 PEEK ROD 1608451070 6.0 X 6.9MM STR 70MM |
| 00763000242503 - MSB Reusable Instruments | 2024-05-27 GRAFT DELIVERY 6061007 GUN HANDLE |
| 00763000914103 - MSB Reusable Instruments | 2024-05-27 OSTEOTOME EX0823011 1/4 WIDE SHARP |
| 00763000914110 - MSB Reusable Instruments | 2024-05-27 OSTEOTOME EX0823012 1/2 WIDE SHARP |
| 00763000940454 - Medtronic Reusable Instruments | 2024-05-27 TRIAL X0420013 16DEG 16MM LARGE |
| 00763000940607 - Medtronic Reusable Instruments | 2024-05-27 TRIAL X0420028 20DEG 14MM LARGE |
| 00763000940614 - Medtronic Reusable Instruments | 2024-05-27 TRIAL X0420029 20DEG 16MM LARGE |
| 00763000940621 - Medtronic Reusable Instruments | 2024-05-27 TRIAL X0420030 20DEG 18MM LARGE |