VERTE-STACK®
GUDID 00763000857561
SPACER 6287941 PSR LAT PORTS 9X14X11
MEDTRONIC SOFAMOR DANEK, INC.
Vertebral body prosthesis| Primary Device ID | 00763000857561 |
| NIH Device Record Key | 3dc6eee8-1c5a-4ee5-9e10-5302f9c11b70 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VERTE-STACK® |
| Version Model Number | 6287941 |
| 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 |
Customer Support Contacts
| 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 Dimensions
| Height | 14 Millimeter |
| Width | 9 Millimeter |
| Depth | 11 Millimeter |
| Height | 14 Millimeter |
| Width | 9 Millimeter |
| Depth | 11 Millimeter |
| Height | 14 Millimeter |
| Width | 9 Millimeter |
| Depth | 11 Millimeter |
| Height | 14 Millimeter |
| Width | 9 Millimeter |
| Depth | 11 Millimeter |
| Height | 14 Millimeter |
| Width | 9 Millimeter |
| Depth | 11 Millimeter |
| Height | 14 Millimeter |
| Width | 9 Millimeter |
| Depth | 11 Millimeter |
| Height | 14 Millimeter |
| Width | 9 Millimeter |
| Depth | 11 Millimeter |
| Height | 14 Millimeter |
| Width | 9 Millimeter |
| Depth | 11 Millimeter |
| Height | 14 Millimeter |
| Width | 9 Millimeter |
| Depth | 11 Millimeter |
| Height | 14 Millimeter |
| Width | 9 Millimeter |
| Depth | 11 Millimeter |
| Height | 14 Millimeter |
| Width | 9 Millimeter |
| Depth | 11 Millimeter |
| Height | 14 Millimeter |
| Width | 9 Millimeter |
| Depth | 11 Millimeter |
| Height | 14 Millimeter |
| Width | 9 Millimeter |
| Depth | 11 Millimeter |
| Height | 14 Millimeter |
| Width | 9 Millimeter |
| Depth | 11 Millimeter |
| Height | 14 Millimeter |
| Width | 9 Millimeter |
| Depth | 11 Millimeter |
| Height | 14 Millimeter |
| Width | 9 Millimeter |
| Depth | 11 Millimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000857561 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K052931
FDA Product Code
| MQP | Spinal vertebral body replacement device |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-07 |
| Device Publish Date | 2025-03-28 |
Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.
| 00763000787820 - CD HORIZON® Spinal System | 2025-04-22 ROD 8672045 SEXTANT 45MM TI |
| 00763000857035 - VERTE-STACK® Spinal System | 2025-04-22 SPACER 6276011 CRNS PSR 10 X 11 X 11MM |
| 00763000857059 - VERTE-STACK® Spinal System | 2025-04-22 SPACER 6276211 CORNSTNE PSR 12X11X11MM |
| 00763000857066 - VERTE-STACK® Spinal System | 2025-04-22 SPACER 6276311 CORNSTNE PSR 13X11X11MM |
| 00763000857073 - VERTE-STACK® Spinal System | 2025-04-22 SPACER 6276411 CORNSTNE PSR 4X11X11MM |
| 00763000857080 - VERTE-STACK® Spinal System | 2025-04-22 SPACER 6276511 CORNERSTONE PSR 5X11X11MM |
| 00763000857097 - VERTE-STACK® Spinal System | 2025-04-22 SPACER 6276611 CORNERSTONE PSR 6X11X11MM |
| 00763000857103 - VERTE-STACK® Spinal System | 2025-04-22 SPACER 6276711 CORNERSTONE PSR 7X11X11MM |
Trademark Results [VERTE-STACK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERTE-STACK 78100037 2774125 Dead/Cancelled |
MEDTRONIC SOFAMOR DANEK INC. 2001-12-27 |
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