TRANSLACE™ Spinal Tethering System

GUDID 00763000108403

TENSIONER 8239000 TENSIONER

MEDTRONIC SOFAMOR DANEK, INC.

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
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: 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
• 00763000675035: TENSIONER 8239000 TENSIONER