| 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 |
| 00885074240695 - n/a | 2025-09-30 ACCESSORIES 3299003 GRAFT TAMP |
| 00199150026029 - Medtronic Reusable Instruments | 2025-09-29 COMPRESSOR X0525001 RACK AND PINION |
| 00763000684044 - Medtronic Reusable Instruments | 2025-09-29 INSTRUMENT 950-146 RULER |
| 00763000856700 - VERTE-STACK® Spinal System | 2025-09-29 STRUT 6242064 ANATOMIC 16X14X24MM |
| 00763000879563 - ENDOSKELETON® TCS | 2025-09-29 HANDLE 5210-1016 TCS RATCHETING HANDLE |
| 00763000879587 - ENDOSKELETON® TCS | 2025-09-29 DRIVER 5210-1004 TCS NO 8 HEX STRAIGHT |
| 00763000879600 - ENDOSKELETON® TCS | 2025-09-29 DRIVER 5210-1024 TCS NO 8 HEX U-JOINT |
| 00763000879648 - Endoskeleton™ TCS Interbody System | 2025-09-29 AWL 5210-1062 TCS STRAIGHT FIXED 2MM |