KODIAK PLIF IMPLANT 12X22mm, 6° 10221206K

GUDID 00819824028103

The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The Kodiak Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transformational (TLIF) approach. The implants have a central endplate window to permit packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces, and lateral windows for radiographic visualization. The implants are additively manufactured from Ti-6Al-4V ELI and are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.

MET 1 TECHNOLOGIES, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 00819824028103
• NIH Device Record Key: 912263b9-4c49-4fe1-9ee5-c7d894513673
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KODIAK PLIF IMPLANT 12X22mm, 6°
• Version Model Number: 10221206K
• Catalog Number: 10221206K
• Company DUNS: 080474650
• Company Name: MET 1 TECHNOLOGIES, LLC
• 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: true
• Manufacturing Date: true
• 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: 9154726762
• Email: yone@met1tech.com
• Phone: 9154726762
• Email: yone@met1tech.com
• Phone: 9154726762
• Email: yone@met1tech.com
• Phone: 9154726762
• Email: yone@met1tech.com
• Phone: 9154726762
• Email: yone@met1tech.com
• Phone: 9154726762
• Email: yone@met1tech.com
• Phone: 9154726762
• Email: yone@met1tech.com
• Phone: 9154726762
• Email: yone@met1tech.com
• Phone: 9154726762
• Email: yone@met1tech.com
• Phone: 9154726762
• Email: yone@met1tech.com
• Phone: 9154726762
• Email: yone@met1tech.com
• Phone: 9154726762
• Email: yone@met1tech.com
• Phone: 9154726762
• Email: yone@met1tech.com
• Phone: 9154726762
• Email: yone@met1tech.com
• Phone: 9154726762
• Email: yone@met1tech.com
• Phone: 9154726762
• Email: yone@met1tech.com
• Phone: 9154726762
• Email: yone@met1tech.com

Device Dimensions

• Angle: 6 degree
• Height: 12 Millimeter
• Width: 9 Millimeter
• Length: 22 Millimeter
• Angle: 6 degree
• Height: 12 Millimeter
• Width: 9 Millimeter
• Length: 22 Millimeter
• Angle: 6 degree
• Height: 12 Millimeter
• Width: 9 Millimeter
• Length: 22 Millimeter
• Angle: 6 degree
• Height: 12 Millimeter
• Width: 9 Millimeter
• Length: 22 Millimeter
• Angle: 6 degree
• Height: 12 Millimeter
• Width: 9 Millimeter
• Length: 22 Millimeter
• Angle: 6 degree
• Height: 12 Millimeter
• Width: 9 Millimeter
• Length: 22 Millimeter
• Angle: 6 degree
• Height: 12 Millimeter
• Width: 9 Millimeter
• Length: 22 Millimeter
• Angle: 6 degree
• Height: 12 Millimeter
• Width: 9 Millimeter
• Length: 22 Millimeter
• Angle: 6 degree
• Height: 12 Millimeter
• Width: 9 Millimeter
• Length: 22 Millimeter
• Angle: 6 degree
• Height: 12 Millimeter
• Width: 9 Millimeter
• Length: 22 Millimeter
• Angle: 6 degree
• Height: 12 Millimeter
• Width: 9 Millimeter
• Length: 22 Millimeter
• Angle: 6 degree
• Height: 12 Millimeter
• Width: 9 Millimeter
• Length: 22 Millimeter
• Angle: 6 degree
• Height: 12 Millimeter
• Width: 9 Millimeter
• Length: 22 Millimeter
• Angle: 6 degree
• Height: 12 Millimeter
• Width: 9 Millimeter
• Length: 22 Millimeter
• Angle: 6 degree
• Height: 12 Millimeter
• Width: 9 Millimeter
• Length: 22 Millimeter
• Angle: 6 degree
• Height: 12 Millimeter
• Width: 9 Millimeter
• Length: 22 Millimeter
• Angle: 6 degree
• Height: 12 Millimeter
• Width: 9 Millimeter
• Length: 22 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819824028103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230851

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[00819824028103]

Moist Heat or Steam Sterilization

[00819824028103]

Moist Heat or Steam Sterilization

[00819824028103]

Moist Heat or Steam Sterilization

[00819824028103]

Moist Heat or Steam Sterilization

[00819824028103]

Moist Heat or Steam Sterilization

[00819824028103]

Moist Heat or Steam Sterilization

[00819824028103]

Moist Heat or Steam Sterilization

[00819824028103]

Moist Heat or Steam Sterilization

[00819824028103]

Moist Heat or Steam Sterilization

[00819824028103]

Moist Heat or Steam Sterilization

[00819824028103]

Moist Heat or Steam Sterilization

[00819824028103]

Moist Heat or Steam Sterilization

[00819824028103]

Moist Heat or Steam Sterilization

[00819824028103]

Moist Heat or Steam Sterilization

[00819824028103]

Moist Heat or Steam Sterilization

[00819824028103]

Moist Heat or Steam Sterilization

[00819824028103]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-03
• Device Publish Date: 2023-06-23

Devices Manufactured by MET 1 TECHNOLOGIES, LLC

• 00819824028905 - 07x22x6° KODIAK PLIF TRIAL: 2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve
• 00819824028912 - 08x22x6° KODIAK PLIF TRIAL: 2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve
• 00819824028929 - 09x22x6° KODIAK PLIF TRIAL: 2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve
• 00819824028936 - 10x22x6° KODIAK PLIF TRIAL: 2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve
• 00819824028943 - 11x22x6° KODIAK PLIF TRIAL: 2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve
• 00819824028950 - 12x22x6° KODIAK PLIF TRIAL: 2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve
• 00819824028967 - 13x22x6° KODIAK PLIF TRIAL: 2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve
• 00819824028974 - 14x22x6° KODIAK PLIF TRIAL: 2023-10-09 The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the ve