ATLANTIS® Anterior Cervical Plate System

GUDID 00763000868093

PLATE 6190037 ANTERIOR CERVICAL 37.5MM

MEDTRONIC SOFAMOR DANEK, INC.

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00763000868093
• NIH Device Record Key: 4434569c-e06d-4428-af5e-7f82ff8638d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATLANTIS® Anterior Cervical Plate System
• Version Model Number: 6190037
• 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
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000868093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063100

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00763000868093]

Moist Heat or Steam Sterilization

[00763000868093]

Moist Heat or Steam Sterilization

[00763000868093]

Moist Heat or Steam Sterilization

[00763000868093]

Moist Heat or Steam Sterilization

[00763000868093]

Moist Heat or Steam Sterilization

[00763000868093]

Moist Heat or Steam Sterilization

[00763000868093]

Moist Heat or Steam Sterilization

[00763000868093]

Moist Heat or Steam Sterilization

[00763000868093]

Moist Heat or Steam Sterilization

[00763000868093]

Moist Heat or Steam Sterilization

[00763000868093]

Moist Heat or Steam Sterilization

[00763000868093]

Moist Heat or Steam Sterilization

[00763000868093]

Moist Heat or Steam Sterilization

[00763000868093]

Moist Heat or Steam Sterilization

[00763000868093]

Moist Heat or Steam Sterilization

[00763000868093]

Moist Heat or Steam Sterilization

[00763000868093]

Moist Heat or Steam Sterilization

[00763000868093]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-12
• Device Publish Date: 2024-02-02

On-Brand Devices [ATLANTIS® Anterior Cervical Plate System]

• 00613994866509: PLATE 9010000224 ATL VIS ELITE 4LEV 75MM
• 00613994866493: PLATE 9010000223 ATL VIS ELT 3LEV 72.5MM
• 00613994866486: PLATE 9010000222 ATL VIS ELITE 3LEV 70MM
• 00613994866479: PLATE 9010000221 ATL VIS ELT 3LEV 67.5MM
• 00613994866462: PLATE 9010000220 ATL VIS ELITE 3LEV 65MM
• 00613994866455: PLATE 9010000219 ATL VIS ELT 3LEV 62.5MM
• 00613994866448: PLATE 9010000218 ATL VIS ELITE 3LEV 60MM
• 00613994866431: PLATE 9010000217 ATL VIS ELT 3LEV 57.5MM
• 00613994866424: PLATE 9010000216 ATL VIS ELITE 3LEV 55MM
• 00613994866417: PLATE 9010000215 ATL VIS ELT 3LEV 52.5MM
• 00613994866400: PLATE 9010000214 ATL VIS ELITE 2LEV 50MM
• 00613994866394: PLATE 9010000213 ATL VIS ELT 2LEV 47.5MM
• 00613994866387: PLATE 9010000212 ATL VIS ELITE 2LEV 45MM
• 00613994866370: PLATE 9010000211 ATL VIS ELT 2LEV 42.5MM
• 00613994866363: PLATE 9010000210 ATL VIS ELITE 2LEV 40MM
• 00613994866356: PLATE 9010000209 ATL VIS ELT 2LEV 37.5MM
• 00613994866349: PLATE 9010000208 ATL VIS ELITE 2LEV 35MM
• 00613994866332: PLATE 9010000207 ATL VIS ELT 2LEV 32.5MM
• 00613994866325: PLATE 9010000206 ATL VIS ELITE 1LEV 30MM
• 00613994866318: PLATE 9010000205 ATL VIS ELT 1LEV 27.5MM
• 00613994866301: PLATE 9010000204 ATL VIS ELITE 1LEV 25MM
• 00613994866295: PLATE 9010000203 ATL VIS ELITE 1LEV 23MM
• 00613994866288: PLATE 9010000202 ATL VIS ELITE 1LEV 21MM
• 00613994866271: PLATE 9010000201 ATL VIS ELITE 1LEV 19MM
• 00613994866264: PLATE 9010000234 ATL VIS ELITE 2LEV 40MM
• 00613994866257: PLATE 9010000233 ATL VIS ELT 2LEV 37.5MM
• 00613994866240: PLATE 9010000232 ATL VIS ELITE 2LEV 35MM
• 00613994866233: PLATE 9010000231 ATL VIS ELT 2LEV 32.5MM
• 00613994866226: PLATE 9010000230 ATL VIS ELITE 1LEV 30MM
• 00613994866219: PLATE 9010000229 ATL VIS ELT 1LEV 27.5MM
• 00613994866202: PLATE 9010000228 ATL VIS ELITE 1LEV 25MM
• 00613994866196: PLATE 9010000227 ATL VIS ELITE 1LEV 23MM
• 00613994866189: PLATE 9010000226 ATL VIS ELITE 1LEV 21MM
• 00613994866172: PLATE 9010000225 ATL VIS ELT 4LEV 77.5MM
• 00613994857460: CADDY X0810599 ST SCREW CADDY RD ELITE
• 00613994857446: CADDY X0810597 SD SCREW CADDY ELITE
• 00613994625335: PLATE 7200047 ATL VISION ELITE 47.5MM
• 00613994625328: PLATE 7200050 ATL VISION ELITE 50MM
• 00613994625311: PLATE 7200052 ATL VISION ELITE 52.5MM
• 00613994625304: PLATE 7200055 ATL VISION ELITE 55MM
• 00613994625298: PLATE 7200057 ATL VISION ELITE 57.5MM
• 00613994625281: PLATE 7200060 ATL VISION ELITE 60MM
• 00613994625274: PLATE 7200062 ATL VISION ELITE 62.5MM
• 00613994625267: PLATE 7200065 ATL VISION ELITE 65MM
• 00613994625250: PLATE 7200067 ATL VISION ELITE 67.5MM
• 00613994625243: PLATE 7200070 ATL VISION ELITE 70MM
• 00613994625236: PLATE 7200072 ATL VISION ELITE 72.5MM
• 00613994625229: PLATE 7200075 ATL VISION ELITE 75MM
• 00613994625212: PLATE 7200019 ATL VISION ELITE 19MM
• 00613994625205: PLATE 7200021 ATL VISION ELITE 21MM