Impulse AM Interbody Spacer System 0722-1632N

GUDID 00842048141440

16H X 32L X 8W Impulse AM Neutral Spacer

DEGEN MEDICAL, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00842048141440
• NIH Device Record Key: 73b979cc-68a0-4fde-bb80-b91871fbf42d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Impulse AM Interbody Spacer System
• Version Model Number: 0722-1632N
• Catalog Number: 0722-1632N
• 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
• 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

• Height: 16 Millimeter
• Width: 8 Millimeter
• Length: 32 Millimeter
• Height: 16 Millimeter
• Width: 8 Millimeter
• Length: 32 Millimeter
• Height: 16 Millimeter
• Width: 8 Millimeter
• Length: 32 Millimeter
• Height: 16 Millimeter
• Width: 8 Millimeter
• Length: 32 Millimeter
• Height: 16 Millimeter
• Width: 8 Millimeter
• Length: 32 Millimeter
• Height: 16 Millimeter
• Width: 8 Millimeter
• Length: 32 Millimeter
• Height: 16 Millimeter
• Width: 8 Millimeter
• Length: 32 Millimeter
• Height: 16 Millimeter
• Width: 8 Millimeter
• Length: 32 Millimeter
• Height: 16 Millimeter
• Width: 8 Millimeter
• Length: 32 Millimeter
• Height: 16 Millimeter
• Width: 8 Millimeter
• Length: 32 Millimeter
• Height: 16 Millimeter
• Width: 8 Millimeter
• Length: 32 Millimeter
• Height: 16 Millimeter
• Width: 8 Millimeter
• Length: 32 Millimeter
• Height: 16 Millimeter
• Width: 8 Millimeter
• Length: 32 Millimeter
• Height: 16 Millimeter
• Width: 8 Millimeter
• Length: 32 Millimeter
• Height: 16 Millimeter
• Width: 8 Millimeter
• Length: 32 Millimeter
• Height: 16 Millimeter
• Width: 8 Millimeter
• Length: 32 Millimeter
• Height: 16 Millimeter
• Width: 8 Millimeter
• Length: 32 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842048141440 [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