WAVE D SPINAL SYSTEM

GUDID 00643169245181

CAGE 2620924 WAVE D 9MM X 24MM 12DEG

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00643169245181
• NIH Device Record Key: 2714afd1-45bb-45e5-969f-275931f2ac7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WAVE D SPINAL SYSTEM
• Version Model Number: 2620924
• 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

Device Dimensions

• Angle: 12 degree
• Angle: 12 degree
• Angle: 12 degree
• Angle: 12 degree
• Angle: 12 degree
• Angle: 12 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169245181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121333

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-06-30

On-Brand Devices [WAVE D SPINAL SYSTEM]

• 00643169400535: DISTRACTOR X0113137 WAVE D 6D 13X28
• 00643169400528: DISTRACTOR X0113136 WAVE D 6D 12X28
• 00643169400511: DISTRACTOR X0113135 WAVE D 6D 11X28
• 00643169400504: DISTRACTOR X0113134 WAVE D 6D 10X28
• 00643169333956: CAGE X0113133 WAVE D IB 6D 13X28
• 00643169333949: CAGE X0113132 WAVE D IB 6D 12X28
• 00643169333932: CAGE X0113131 WAVE D IB 6D 11X28
• 00643169333925: CAGE X0113130 WAVE D IB 6D 10X28
• 00643169245419: INSERTER 2670002 WAVE OUTER TUBE
• 00643169245402: INSERTER 2670001 WAVE INNER TUBE
• 00643169245396: DISTRACTOR 2671214 DSTCTR WAVE 14MM12DEG
• 00643169245389: DISTRACTOR 2671213 DSTCTR WAVE 13MM12DEG
• 00643169245372: CAP 2670015 WAVE IMPACTOR INSERTER CAP
• 00643169245358: THANDLE 2670012 DISTRACTOR T-HANDLE LONG
• 00643169245341: THANDLE 2670011 T-HANDLE FOR DISTRACTOR
• 00643169245310: ROD 2670005 WAVE DISTRACTION ROD 28 MM
• 00643169245303: ROD 2670004 WAVE DISTRACTION ROD 24 MM
• 00643169245297: HANDLE 2670003 WAVE DISTRACTION HANDLE
• 00643169245280: CAGE 2621324 WAVE D 13MM X 24MM 12DEG
• 00643169245273: CAGE 2621424 WAVE D 14MM X 24MM 12DEG
• 00643169245266: CAGE 2661424 WAVE D 14MM X 24MM 6DEG
• 00643169245259: CAGE 2661324 WAVE D 13MM X 24MM 6DEG
• 00643169245242: CAGE 2621224 WAVE D 12MM X 24MM 12DEG
• 00643169245235: CAGE 2661224 WAVE D 12MM X 24MM 6DEG
• 00643169245228: CAGE 2621124 WAVE D 11MM X 24MM 12DEG
• 00643169245211: CAGE 2661124 WAVE D 11MM X 24MM 6DEG
• 00643169245204: CAGE 2621024 WAVE D 10MM X 24MM 12DEG
• 00643169245198: CAGE 2661024 WAVE D 10MM X 24MM 6DEG
• 00643169245181: CAGE 2620924 WAVE D 9MM X 24MM 12DEG
• 00643169245174: CAGE 2660924 WAVE D 9MM X 24MM 6DEG
• 00643169245167: DISTRACTOR 2671212 DSTCTR WAVE 12MM12DEG
• 00643169245150: DISTRACTOR 2671211 DSTCTR WAVE 11MM12DEG
• 00643169245143: DISTRACTOR 2671210 DSTCTR WAVE 10MM12DEG
• 00643169245136: DISTRACTOR 2671209 DSTCTR WAVE 9MM 12DEG
• 00643169245129: DISTRACTOR 2670614 DSTCTR WAVE 14MM 6DEG
• 00643169245112: DISTRACTOR 2670613 DSTCTR WAVE 13MM 6DEG
• 00643169245105: DISTRACTOR 2670612 DSTCTR WAVE 12MM 6DEG
• 00643169245099: DISTRACTOR 2670611 DSTCTR WAVE 11MM 6DEG
• 00643169245082: DISTRACTOR 2670610 DSTCTR WAVE 10MM 6DEG
• 00643169245075: DISTRACTOR 2670609 DSTCTR WAVE 9MM 6DEG
• 00643169245051: PESTLE 2670008 WAVE PESTLE
• 00643169245044: FUNNEL 2670007 WAVE FUNNEL