T2 SCEPTOR™ Spinal System
GUDID 00613994218797
MESH 9351915 19MM ENDCAP 15 DEGREE
MEDTRONIC SOFAMOR DANEK, INC.
Polymeric spinal fusion cage, sterile| Primary Device ID | 00613994218797 |
| NIH Device Record Key | 5b449dfe-4cdf-4497-853c-5224287ffc29 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | T2 SCEPTOR™ Spinal System |
| Version Model Number | 9351915 |
| 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
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
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| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994218797 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K063491
FDA Product Code
| MQP | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
Moist Heat or Steam Sterilization
[00613994218797]
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 | 2015-08-21 |
On-Brand Devices [T2 SCEPTOR™ Spinal System]
| 00613994218872 | MESH 9352515 25MM ENDCAP 15 DEGREE |
| 00613994218858 | MESH 9352504 25MM ENDCAP 4 DEGREE |
| 00613994218841 | MESH 9352500 25MM ENDCAP 0 DEGREE |
| 00613994218834 | MESH 9352215 22MM ENDCAP 15 DEGREE |
| 00613994218827 | MESH 9352208 22MM ENDCAP 8 DEGREE |
| 00613994218810 | MESH 9352204 22MM ENDCAP 4 DEGREE |
| 00613994218803 | MESH 9352200 22MM ENDCAP 0 DEGREE |
| 00613994218797 | MESH 9351915 19MM ENDCAP 15 DEGREE |
| 00613994218780 | MESH 9351908 19MM ENDCAP 8 DEGREE |
| 00613994218773 | MESH 9351904 19MM ENDCAP 4 DEGREE |
Trademark Results [T2 SCEPTOR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 T2 SCEPTOR 77063468 3917315 Dead/Cancelled |
Warsaw Orthopedic, Inc. 2006-12-13 |
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