Impulse AM Interbody Spacer System 0722-1126L12

GUDID 00842048139218

11H X 26L X 8W X 12DEG Impulse AM Lordotic Spacer

DEGEN MEDICAL, INC.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 00842048139218
• NIH Device Record Key: c914a95f-8645-45e5-a6ed-e17b0527de7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Impulse AM Interbody Spacer System
• Version Model Number: 0722-1126L12
• Catalog Number: 0722-1126L12
• Company DUNS: 078812602
• Company Name: DEGEN MEDICAL, 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: true
• Expiration Date: true
• 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(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com
• Phone: +1(877)240-7838
• Email: customerservice@degenmedical.com

Device Dimensions

• Width: 8 Millimeter
• Height: 11 Millimeter
• Angle: 12 degree
• Length: 26 Millimeter
• Width: 8 Millimeter
• Height: 11 Millimeter
• Angle: 12 degree
• Length: 26 Millimeter
• Width: 8 Millimeter
• Height: 11 Millimeter
• Angle: 12 degree
• Length: 26 Millimeter
• Width: 8 Millimeter
• Height: 11 Millimeter
• Angle: 12 degree
• Length: 26 Millimeter
• Width: 8 Millimeter
• Height: 11 Millimeter
• Angle: 12 degree
• Length: 26 Millimeter
• Width: 8 Millimeter
• Height: 11 Millimeter
• Angle: 12 degree
• Length: 26 Millimeter
• Width: 8 Millimeter
• Height: 11 Millimeter
• Angle: 12 degree
• Length: 26 Millimeter
• Width: 8 Millimeter
• Height: 11 Millimeter
• Angle: 12 degree
• Length: 26 Millimeter
• Width: 8 Millimeter
• Height: 11 Millimeter
• Angle: 12 degree
• Length: 26 Millimeter
• Width: 8 Millimeter
• Height: 11 Millimeter
• Angle: 12 degree
• Length: 26 Millimeter
• Width: 8 Millimeter
• Height: 11 Millimeter
• Angle: 12 degree
• Length: 26 Millimeter
• Width: 8 Millimeter
• Height: 11 Millimeter
• Angle: 12 degree
• Length: 26 Millimeter
• Width: 8 Millimeter
• Height: 11 Millimeter
• Angle: 12 degree
• Length: 26 Millimeter
• Width: 8 Millimeter
• Height: 11 Millimeter
• Angle: 12 degree
• Length: 26 Millimeter
• Width: 8 Millimeter
• Height: 11 Millimeter
• Angle: 12 degree
• Length: 26 Millimeter
• Width: 8 Millimeter
• Height: 11 Millimeter
• Angle: 12 degree
• Length: 26 Millimeter
• Width: 8 Millimeter
• Height: 11 Millimeter
• Angle: 12 degree
• Length: 26 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842048139218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210090

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: 2021-12-29
• Device Publish Date: 2021-12-21

On-Brand Devices [Impulse AM Interbody Spacer System]

• 00842048123347: Implant Retriever, 12mm
• 00842048123330: Implant Retriever, 10mm
• 00842048123323: Implant Retriever, 8mm
• 00842048143543: 16H X 36L X 12W Impulse AM Anatomic Spacer
• 00842048143536: 15H X 36L X 12W Impulse AM Anatomic Spacer
• 00842048143529: 14H X 36L X 12W Impulse AM Anatomic Spacer
• 00842048143512: 13H X 36L X 12W Impulse AM Anatomic Spacer
• 00842048143505: 12H X 36L X 12W Impulse AM Anatomic Spacer
• 00842048143499: 11H X 36L X 12W Impulse AM Anatomic Spacer
• 00842048143482: 10H X 36L X 12W Impulse AM Anatomic Spacer
• 00842048143475: 9H X 36L X 12W Impulse AM Anatomic Spacer
• 00842048143468: 8H X 36L X 12W Impulse AM Anatomic Spacer
• 00842048143451: 7H X 36L X 12W Impulse AM Anatomic Spacer
• 00842048143444: 16H X 32L X 12W Impulse AM Anatomic Spacer
• 00842048143437: 15H X 32L X 12W Impulse AM Anatomic Spacer
• 00842048143420: 14H X 32L X 12W Impulse AM Anatomic Spacer
• 00842048143413: 13H X 32L X 12W Impulse AM Anatomic Spacer
• 00842048143406: 12H X 32L X 12W Impulse AM Anatomic Spacer
• 00842048143390: 11H X 32L X 12W Impulse AM Anatomic Spacer
• 00842048143383: 10H X 32L X 12W Impulse AM Anatomic Spacer
• 00842048143376: 9H X 32L X 12W Impulse AM Anatomic Spacer
• 00842048143369: 8H X 32L X 12W Impulse AM Anatomic Spacer
• 00842048143352: 7H X 32L X 12W Impulse AM Anatomic Spacer
• 00842048143345: 16H X 26L X 12W Impulse AM Anatomic Spacer
• 00842048143338: 15H X 26L X 12W Impulse AM Anatomic Spacer
• 00842048143321: 14H X 26L X 12W Impulse AM Anatomic Spacer
• 00842048143314: 13H X 26L X 12W Impulse AM Anatomic Spacer
• 00842048143307: 12H X 26L X 12W Impulse AM Anatomic Spacer
• 00842048143291: 11H X 26L X 12W Impulse AM Anatomic Spacer
• 00842048143284: 10H X 26L X 12W Impulse AM Anatomic Spacer
• 00842048143277: 9H X 26L X 12W Impulse AM Anatomic Spacer
• 00842048143260: 8H X 26L X 12W Impulse AM Anatomic Spacer
• 00842048143253: 7H X 26L X 12W Impulse AM Anatomic Spacer
• 00842048143222: 14H X 22L X 12W Impulse AM Anatomic Spacer
• 00842048143215: 13H X 22L X 12W Impulse AM Anatomic Spacer
• 00842048143208: 12H X 22L X 12W Impulse AM Anatomic Spacer
• 00842048143192: 11H X 22L X 12W Impulse AM Anatomic Spacer
• 00842048143185: 10H X 22L X 12W Impulse AM Anatomic Spacer
• 00842048143178: 9H X 22L X 12W Impulse AM Anatomic Spacer
• 00842048143161: 8H X 22L X 12W Impulse AM Anatomic Spacer
• 00842048143154: 7H X 22L X 12W Impulse AM Anatomic Spacer
• 00842048143147: 16H X 36L X 10W Impulse AM Anatomic Spacer
• 00842048143130: 15H X 36L X 10W Impulse AM Anatomic Spacer
• 00842048143123: 14H X 36L X 10W Impulse AM Anatomic Spacer
• 00842048143116: 13H X 36L X 10W Impulse AM Anatomic Spacer
• 00842048143109: 12H X 36L X 10W Impulse AM Anatomic Spacer
• 00842048143093: 11H X 36L X 10W Impulse AM Anatomic Spacer
• 00842048143086: 10H X 36L X 10W Impulse AM Anatomic Spacer
• 00842048143079: 9H X 36L X 10W Impulse AM Anatomic Spacer
• 00842048143062: 8H X 36L X 10W Impulse AM Anatomic Spacer