| Primary Device ID | 00763000855109 |
| NIH Device Record Key | 536bb576-ef58-4d84-aa67-570c023c984f |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 6248486 |
| 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 | 00763000855109 [Primary] |
| MQP | Spinal vertebral body replacement device |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000855109]
Moist Heat or Steam Sterilization
[00763000855109]
Moist Heat or Steam Sterilization
[00763000855109]
Moist Heat or Steam Sterilization
[00763000855109]
Moist Heat or Steam Sterilization
[00763000855109]
Moist Heat or Steam Sterilization
[00763000855109]
Moist Heat or Steam Sterilization
[00763000855109]
Moist Heat or Steam Sterilization
[00763000855109]
Moist Heat or Steam Sterilization
[00763000855109]
Moist Heat or Steam Sterilization
[00763000855109]
Moist Heat or Steam Sterilization
[00763000855109]
Moist Heat or Steam Sterilization
[00763000855109]
Moist Heat or Steam Sterilization
[00763000855109]
Moist Heat or Steam Sterilization
[00763000855109]
Moist Heat or Steam Sterilization
[00763000855109]
Moist Heat or Steam Sterilization
[00763000855109]
Moist Heat or Steam Sterilization
[00763000855109]
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 |
| 00763000787660 - TSRH® Spinal System | 2025-12-05 ROD 8370040 TSR2D PCUT BENT 40MMX5.5MM |
| 00199150044375 - Medtronic Reusable Instruments | 2025-12-02 CORONAL BENDER FULCRUM LEFT |
| 00199150044382 - Medtronic Reusable Instruments | 2025-12-02 CORONAL BENDER FULCRUM RIGHT |
| 00199150044399 - Medtronic Reusable Instruments | 2025-12-02 CORONAL BENDER FULCRUM EXTENSION |
| 00199150055180 - Medtronic Reusable Instruments | 2025-12-02 SPREADER EX0925010 14.5MM CERVICAL DISC |
| 00199150041923 - Medtronic Reusable Instruments | 2025-11-28 FUNNEL EX0725013 CURVED |
| 00199150041930 - Medtronic Reusable Instruments | 2025-11-28 TAMP EX0725014 CURVED FUNNEL |
| 00199150043521 - Medtronic Reusable Instruments | 2025-11-28 DRIVER EX0725015 U-JOINT SHORT TIP |