| Primary Device ID | 00763000855123 |
| NIH Device Record Key | 58a88a31-676e-4426-b905-e1d04a412a81 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 6248564 |
| 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 | 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000855123 [Primary] |
| MQP | Spinal vertebral body replacement device |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000855123]
Moist Heat or Steam Sterilization
[00763000855123]
Moist Heat or Steam Sterilization
[00763000855123]
Moist Heat or Steam Sterilization
[00763000855123]
Moist Heat or Steam Sterilization
[00763000855123]
Moist Heat or Steam Sterilization
[00763000855123]
Moist Heat or Steam Sterilization
[00763000855123]
Moist Heat or Steam Sterilization
[00763000855123]
Moist Heat or Steam Sterilization
[00763000855123]
Moist Heat or Steam Sterilization
[00763000855123]
Moist Heat or Steam Sterilization
[00763000855123]
Moist Heat or Steam Sterilization
[00763000855123]
Moist Heat or Steam Sterilization
[00763000855123]
Moist Heat or Steam Sterilization
[00763000855123]
Moist Heat or Steam Sterilization
[00763000855123]
Moist Heat or Steam Sterilization
[00763000855123]
Moist Heat or Steam Sterilization
[00763000855123]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-14 |
| Device Publish Date | 2024-10-04 |
| 00763000681470 - CD HORIZON® Spinal System | 2025-05-23 INSTRUMENT 7576304 REDUCTION EXTNDR B SL |
| 00763000788001 - CD HORIZON® Spinal System | 2025-05-23 ROD 8672095 SEXTANT 95MM TI |
| 00763000855734 - PYRAMESH® C Titanium Mesh | 2025-05-23 MESH 9051770 PYRAMESH 17MMX22MMX70MM |
| 00763000856441 - PYRAMESH® Implant System | 2025-05-23 MESH 905-408 PYRM 10 X 14 OVOID X 8MM |
| 00763000856540 - PYRAMESH® Implant System | 2025-05-23 MESH 905-515 PYRM 13 X 17 OVOID X 15MM |
| 00763000663384 - ZEVO™ Anterior Cervical Plate System | 2025-05-20 PLATE 3001015 ZEVO 15MM 1 LVL |
| 00763000878054 - CD HORIZON® Spinal System | 2025-05-20 RASP 6630915 PARALLEL 6MMX15MMX12MM |
| 00763000242510 - MSB Reusable Instruments | 2025-05-19 GRAFT DELIVERY 6061020 LOADING PLATFORM |