Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology

GUDID 00763000202996

SPACER 84332809 ADAPTIX 28MM X 9MM

MEDTRONIC SOFAMOR DANEK, INC.

Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system Intervertebral-body internal spinal fixation system

• Primary Device ID: 00763000202996
• NIH Device Record Key: 8826d419-16db-4ef1-b73b-47819a807d41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology
• Version Model Number: 84332809
• Company DUNS: 830350380
• Company Name: MEDTRONIC SOFAMOR DANEK, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000202996 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201267

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-12
• Device Publish Date: 2020-10-04

On-Brand Devices [Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology]

• 00763000203252: SPACER 84333816 ADAPTIX 38MM X 16MM
• 00763000203245: SPACER 84333815 ADAPTIX 38MM X 15MM
• 00763000203238: SPACER 84333814 ADAPTIX 38MM X 14MM
• 00763000203221: SPACER 84333813 ADAPTIX 38MM X 13MM
• 00763000203214: SPACER 84333812 ADAPTIX 38MM X 12MM
• 00763000203207: SPACER 84333811 ADAPTIX 38MM X 11MM
• 00763000203191: SPACER 84333810 ADAPTIX 38MM X 10MM
• 00763000203184: SPACER 84333809 ADAPTIX 38MM X 9MM
• 00763000203177: SPACER 84333808 ADAPTIX 38MM X 8MM
• 00763000203160: SPACER 84333416 ADAPTIX 34MM X 16MM
• 00763000203153: SPACER 84333415 ADAPTIX 34MM X 15MM
• 00763000203146: SPACER 84333414 ADAPTIX 34MM X 14MM
• 00763000203139: SPACER 84333413 ADAPTIX 34MM X 13MM
• 00763000203122: SPACER 84333412 ADAPTIX 34MM X 12MM
• 00763000203115: SPACER 84333411 ADAPTIX 34MM X 11MM
• 00763000203108: SPACER 84333410 ADAPTIX 34MM X 10MM
• 00763000203092: SPACER 84333409 ADAPTIX 34MM X 9MM
• 00763000203085: SPACER 84333408 ADAPTIX 34MM X 8MM
• 00763000203078: SPACER 84333407 ADAPTIX 34MM X 7MM
• 00763000203061: SPACER 84332816 ADAPTIX 28MM X 16MM
• 00763000203054: SPACER 84332815 ADAPTIX 28MM X 15MM
• 00763000203047: SPACER 84332814 ADAPTIX 28MM X 14MM
• 00763000203030: SPACER 84332813 ADAPTIX 28MM X 13MM
• 00763000203023: SPACER 84332812 ADAPTIX 28MM X 12MM
• 00763000203016: SPACER 84332811 ADAPTIX 28MM X 11MM
• 00763000203009: SPACER 84332810 ADAPTIX 28MM X 10MM
• 00763000202996: SPACER 84332809 ADAPTIX 28MM X 9MM
• 00763000202989: SPACER 84332808 ADAPTIX 28MM X 8MM
• 00763000202972: SPACER 84332807 ADAPTIX 28MM X 7MM
• 00763000202965: SPACER 84332806 ADAPTIX 28MM X 6MM
• 00763000202958: SPACER 84332416 ADAPTIX 24MM X 16MM
• 00763000202941: SPACER 84332415 ADAPTIX 24MM X 15MM
• 00763000202934: SPACER 84332414 ADAPTIX 24MM X 14MM
• 00763000202927: SPACER 84332413 ADAPTIX 24MM X 13MM
• 00763000202910: SPACER 84332412 ADAPTIX 24MM X 12MM
• 00763000202903: SPACER 84332411 ADAPTIX 24MM X 11MM
• 00763000202897: SPACER 84332410 ADAPTIX 24MM X 10MM
• 00763000202880: SPACER 84332409 ADAPTIX 24MM X 9MM
• 00763000202873: SPACER 84332408 ADAPTIX 24MM X 8MM
• 00763000202866: SPACER 84332407 ADAPTIX 24MM X 7MM
• 00763000202859: SPACER 84332406 ADAPTIX 24MM X 6MM
• 00763000357559: TRAY 2968001 TLIF-DLIF NAV INSERTER SET
• 00763000357535: TRAY 3991003 CAPSTONE NAVIGATED TRIALS