TRANSLACE™ Spinal Tethering System
GUDID 00763000108403
TENSIONER 8239000 TENSIONER
MEDTRONIC SOFAMOR DANEK, INC.
Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner Internal spinal fixation system cable tensioner| Primary Device ID | 00763000108403 |
| NIH Device Record Key | f768cdae-67a8-421e-88a3-ae9707e5ceed |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRANSLACE™ Spinal Tethering System |
| Version Model Number | 8239000 |
| 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 |
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 | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000108403 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K163181
FDA Product Code
| OWI | Bone fixation cerclage, sublaminar |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00763000108403]
Moist Heat or Steam Sterilization
[00763000108403]
Moist Heat or Steam Sterilization
[00763000108403]
Moist Heat or Steam Sterilization
[00763000108403]
Moist Heat or Steam Sterilization
[00763000108403]
Moist Heat or Steam Sterilization
[00763000108403]
Moist Heat or Steam Sterilization
[00763000108403]
Moist Heat or Steam Sterilization
[00763000108403]
Moist Heat or Steam Sterilization
[00763000108403]
Moist Heat or Steam Sterilization
[00763000108403]
Moist Heat or Steam Sterilization
[00763000108403]
Moist Heat or Steam Sterilization
[00763000108403]
Moist Heat or Steam Sterilization
[00763000108403]
Moist Heat or Steam Sterilization
[00763000108403]
Moist Heat or Steam Sterilization
[00763000108403]
Moist Heat or Steam Sterilization
[00763000108403]
Moist Heat or Steam Sterilization
[00763000108403]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-12 |
| Device Publish Date | 2021-07-03 |
On-Brand Devices [TRANSLACE™ Spinal Tethering System]
| 00643169742949 | TRAY 8239100 TRANSLACE INSTRUMENTS |
| 00643169726932 | TENSIONER 8239000 TENSIONER |
| 00643169726925 | TETHER 8219500 TETHER |
| 00643169726918 | CONNECTOR 8205300 5.5/6.0 CONNECTOR |
| 00763000108397 | TETHER 8219500 TETHER |
| 00763000108380 | CONNECTOR 8205300 CONNECTOR |
| 00763000099701 | TRAY 8239100 TRANSLACE INSTRUMENTS |
| 00763000333409 | TETHER 9010007014 0.4MM INSERT ASSEMBLY |
| 00763000333393 | TETHER 9010007013 0.3MM INSERT ASSEMBLY |
| 00763000333386 | TETHER 9010007012 0.2MM INSERT ASSEMBLY |
| 00763000108403 | TENSIONER 8239000 TENSIONER |
Trademark Results [TRANSLACE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRANSLACE 87469368 5612843 Live/Registered |
Warsaw Orthopedic, Inc. 2017-05-31 |
 TRANSLACE 86456468 not registered Dead/Abandoned |
Warsaw Orthopedic, Inc. 2014-11-17 |
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