WAVE O SPINAL SYSTEM

GUDID 00643169244573

CAGE 2720922 WAVE O 9MM X 22MM 12DEG

MEDTRONIC SOFAMOR DANEK, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00643169244573
• NIH Device Record Key: de6b42bb-6e13-44bd-bd5a-109c0194340c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WAVE O SPINAL SYSTEM
• Version Model Number: 2720922
• 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

• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter
• Height: 9 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169244573 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121330

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 O SPINAL SYSTEM]

• 00643169244672: CAGE 2761026 WAVE O 10MM X 26MM 6DEG
• 00643169244665: CAGE 2761122 WAVE O 11MM X 22MM 6DEG
• 00643169244658: CAGE 2761022 WAVE O 10MM X 22MM 6DEG
• 00643169244641: CAGE 2760926 WAVE O 9MM X 26MM 6DEG
• 00643169244634: CAGE 2760922 WAVE O 9MM X 22MM 6DEG
• 00643169244627: CAGE 2761126 WAVE O 11MM X 26MM 6DEG
• 00643169244610: CAGE 2761222 WAVE O 12MM X 22MM 6DEG
• 00643169244603: CAGE 2761226 WAVE O 12MM X 26MM 6DEG
• 00643169244597: CAGE 2761322 WAVE O 13MM X 22MM 6DEG
• 00643169244580: CAGE 2761422 WAVE O 14MM X 22MM 6DEG
• 00643169244573: CAGE 2720922 WAVE O 9MM X 22MM 12DEG
• 00643169244566: CAGE 2720926 WAVE O 9MM X 26MM 12DEG
• 00643169244559: CAGE 2721022 WAVE O 10MM X 22MM 12DEG
• 00643169244542: CAGE 2721026 WAVE O 10MM X 26MM 12DEG
• 00643169244535: CAGE 2721122 WAVE O 11MM X 22MM 12DEG
• 00643169244528: CAGE 2761326 WAVE O 13MM X 26MM 6DEG
• 00643169244511: CAGE 2761426 WAVE O 14MM X 26MM 6DEG
• 00643169244504: CAGE 2721326 WAVE O 13MM X 26MM 12DEG
• 00643169244498: CAGE 2721426 WAVE O 14MM X 26MM 12DEG
• 00643169244481: CAGE 2721422 WAVE O 14MM X 22MM 12DEG