| 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 |
| 00643169465916 - Medtronic Reusable Instruments | 2024-12-30 TAP X1013176 4.5MM SOLID |
| 00681490520089 - n/a | 2024-12-30 INSTRUMENT 8756412 DISTRACTOR PIN 12MM |
| 20763000710525 - CD Horizon™ ModuLeX™ Spinal System | 2024-12-23 DRMAS 559200101 HEAD W/2 SET SCREWS |
| 20763000710532 - CD Horizon™ ModuLeX™ Spinal System | 2024-12-23 RDRMAS 559200102 HEAD W/2 SET SCREWS |
| 00763000857172 - VERTE-STACK® Spinal System | 2024-12-16 SPACER 6277441 CORNERSTONE PSR 4X14X11MM |
| 00763000857387 - VERTE-STACK® Spinal System | 2024-12-16 SPACER 6277006 PSR STRUT 6 X 14 X 11MM |
| 00763000868475 - CORNERSTONE® PSR Cervical Fusion System | 2024-12-16 IMPLANT 6284641 PEEK CRV 14X11X6MM |
| 00763000878818 - NA | 2024-12-16 INSTRUMENT 803-043 GUIDEWIRE |