| 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 |
| 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
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[00613994627698]
Moist Heat or Steam Sterilization
[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 |
| 00763000856816 - VERTE-STACK® Spinal System | 2026-02-10 STRUT 6241086 ANATOMIC 18X16X5MM |
| 00763000856823 - VERTE-STACK® Spinal System | 2026-02-10 STRUT 6242086 ANATOMIC 18X16X24MM |
| 00763000856953 - VERTE-STACK® Spinal System | 2026-02-10 IMPLANT 6240964 ANATOMIC 16X14X9MM |
| 00199150060672 - Medtronic Reusable Instruments | 2026-02-09 ROD HOLDER EX5484303 KERRISON 5.5MM |
| 00199150061983 - Medtronic Reusable Instruments | 2026-01-23 PLIERS X5584165 COMPRESSOR 5.5/6.0 |
| 00763000885199 - n/a | 2026-01-09 INSTRUMENT 9790904 PLATE HOLDING PIN |
| 00199150060115 - Medtronic Reusable Instruments | 2026-01-06 DRIVER X1025034 CANNULATED ASM |
| 00199150062898 - Medtronic Reusable Instruments | 2026-01-06 DRIVER X1025035 CANNULATED REDUCTION |