VERTE-SPAN® Spinal System
GUDID 20721902068342
M4 BREAK-OFF SCREW
MEDTRONIC SOFAMOR DANEK, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 20721902068342 |
| NIH Device Record Key | 7ffdfc70-dafc-4599-add7-4382c1ee0b6d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VERTE-SPAN® Spinal System |
| Version Model Number | 8914000 |
| Company DUNS | 830350380 |
| Company Name | MEDTRONIC SOFAMOR DANEK, INC. |
| Device Count | 2 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00721902068348 [Unit of Use] |
| GS1 | 20721902068342 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K010930
FDA Product Code
| KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
[20721902068342]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-29 |
On-Brand Devices [VERTE-SPAN® Spinal System]
| 00721902035388 | OTHER 8913105 VRTSPN THORACIC CYLINDER L |
| 00721902035289 | OTHER 8912200 VERTSPN THORACOLUMBAR RT E |
| 00721902035234 | OTHER 8912010 VERTSPN THORACOLUMBAR CYLI |
| 20721902068342 | M4 BREAK-OFF SCREW |
Trademark Results [VERTE-SPAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERTE-SPAN 78057621 2613555 Dead/Cancelled |
MEDTRONIC SOFAMOR DANEK INC. 2001-04-10 |
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