FLXfit 15

GUDID M725AT40080

FLXfit 15 Expandable Interbody

CORELINK LLC

Metallic spinal interbody fusion cage

• Primary Device ID: M725AT40080
• NIH Device Record Key: dfb206a2-888a-4d67-b3a4-a1ed5f830dca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLXfit 15
• Version Model Number: AT4008
• Company DUNS: 064191453
• Company Name: CORELINK LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M725AT40080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171519

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[M725AT40080]

Moist Heat or Steam Sterilization

[M725AT40080]

Moist Heat or Steam Sterilization

[M725AT40080]

Moist Heat or Steam Sterilization

[M725AT40080]

Moist Heat or Steam Sterilization

[M725AT40080]

Moist Heat or Steam Sterilization

[M725AT40080]

Moist Heat or Steam Sterilization

[M725AT40080]

Moist Heat or Steam Sterilization

[M725AT40080]

Moist Heat or Steam Sterilization

[M725AT40080]

Moist Heat or Steam Sterilization

[M725AT40080]

Moist Heat or Steam Sterilization

[M725AT40080]

Moist Heat or Steam Sterilization

[M725AT40080]

Moist Heat or Steam Sterilization

[M725AT40080]

Moist Heat or Steam Sterilization

[M725AT40080]

Moist Heat or Steam Sterilization

[M725AT40080]

Moist Heat or Steam Sterilization

[M725AT40080]

Moist Heat or Steam Sterilization

[M725AT40080]

Moist Heat or Steam Sterilization

[M725AT40080]

Moist Heat or Steam Sterilization

[M725AT40080]

Moist Heat or Steam Sterilization

[M725AT40080]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-08
• Device Publish Date: 2022-10-31

On-Brand Devices [FLXfit 15]

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• M725AT40120: FLXfit 15 Expandable Interbody
• M725AT40110: FLXfit 15 Expandable Interbody
• M725AT40100: FLXfit 15 Expandable Interbody
• M725AT40090: FLXfit 15 Expandable Interbody
• M725AT40080: FLXfit 15 Expandable Interbody
• M725AT32130: FLXfit 15 Expandable Interbody
• M725AT32120: FLXfit 15 Expandable Interbody
• M725AT32110: FLXfit 15 Expandable Interbody
• M725AT32100: FLXfit 15 Expandable Interbody
• M725AT32090: FLXfit 15 Expandable Interbody
• M725AT32080: FLXfit 15 Expandable Interbody