Tranquil-L Interbody System

GUDID B678523494S0

DLIF IBD 12x26x50, 12 deg

NEXUS SPINE, L.L.C.

Metallic spinal interbody fusion cage

• Primary Device ID: B678523494S0
• NIH Device Record Key: 7771b635-e04a-41d1-a02b-ded313f4454a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tranquil-L Interbody System
• Version Model Number: 523494s
• Company DUNS: 028137605
• Company Name: NEXUS SPINE, L.L.C.
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Width: 26 Millimeter
• Length: 50 Millimeter
• Height: 12 Millimeter
• Width: 26 Millimeter
• Length: 50 Millimeter
• Height: 12 Millimeter
• Width: 26 Millimeter
• Length: 50 Millimeter
• Height: 12 Millimeter
• Width: 26 Millimeter
• Length: 50 Millimeter
• Height: 12 Millimeter
• Width: 26 Millimeter
• Length: 50 Millimeter
• Height: 12 Millimeter
• Width: 26 Millimeter
• Length: 50 Millimeter
• Height: 12 Millimeter
• Width: 26 Millimeter
• Length: 50 Millimeter
• Height: 12 Millimeter
• Width: 26 Millimeter
• Length: 50 Millimeter
• Height: 12 Millimeter
• Width: 26 Millimeter
• Length: 50 Millimeter
• Height: 12 Millimeter
• Width: 26 Millimeter
• Length: 50 Millimeter
• Height: 12 Millimeter
• Width: 26 Millimeter
• Length: 50 Millimeter
• Height: 12 Millimeter
• Width: 26 Millimeter
• Length: 50 Millimeter
• Height: 12 Millimeter
• Width: 26 Millimeter
• Length: 50 Millimeter
• Height: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B678523494S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233375

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: 2025-09-23
• Device Publish Date: 2025-09-15

On-Brand Devices [Tranquil-L Interbody System]

• B678523506S0: DLIF IBD 16x26x60, 12 deg
• B678523505S0: DLIF IBD 14x26x60, 12 deg
• B678523504S0: DLIF IBD 12x26x60, 12 deg
• B678523503S0: DLIF IBD 10x26x60, 12 deg
• B678523501S0: DLIF IBD 16x26x55, 12 deg
• B678523500S0: DLIF IBD 14x26x55, 12 deg
• B678523499S0: DLIF IBD 12x26x55, 12 deg
• B678523498S0: DLIF IBD 10x26x55, 12 deg
• B678523496S0: DLIF IBD 16x26x50, 12 deg
• B678523495S0: DLIF IBD 14x26x50, 12 deg
• B678523494S0: DLIF IBD 12x26x50, 12 deg
• B678523493S0: DLIF IBD 10x26x50, 12 deg
• B678523491S0: DLIF IBD 16x26x60, 6 deg
• B678523490S0: DLIF IBD 14x26x60, 6 deg
• B678523489S0: DLIF IBD 12x26x60, 6 deg
• B678523488S0: DLIF IBD 10x26x60, 6 deg
• B678523487S0: DLIF IBD 8x26x60, 6 deg
• B678523486S0: DLIF IBD 16x26x55, 6 deg
• B678523485S0: DLIF IBD 14x26x55, 6 deg
• B678523484S0: DLIF IBD 12x26x55, 6 deg
• B678523483S0: DLIF IBD 10x26x55, 6 deg
• B678523482S0: DLIF IBD 8x26x55, 6 deg
• B678523481S0: DLIF IBD 16x26x50, 6 deg
• B678523480S0: DLIF IBD 14x26x50, 6 deg
• B678523479S0: DLIF IBD 12x26x50, 6 deg
• B678523478S0: DLIF IBD 10x26x50, 6 deg
• B678523477S0: DLIF IBD 8x26x50, 6 deg
• B678523476S0: DLIF IBD 16x22x60, 12 deg
• B678523475S0: DLIF IBD 14x22x60, 12 deg
• B678523474S0: DLIF IBD 12x22x60, 12 deg
• B678523473S0: DLIF IBD 10x22x60, 12 deg
• B678523472S0: DLIF IBD 8x22x60, 12 deg
• B678523471S0: DLIF IBD 16x22x55, 12 deg
• B678523470S0: DLIF IBD 14x22x55, 12 deg
• B678523469S0: DLIF IBD 12x22x55, 12 deg
• B678523468S0: DLIF IBD 10x22x55, 12 deg
• B678523467S0: DLIF IBD 8x22x55, 12 deg
• B678523466S0: DLIF IBD 16x22x50, 12 deg
• B678523465S0: DLIF IBD 14x22x50, 12 deg
• B678523464S0: DLIF IBD 12x22x50, 12 deg
• B678523463S0: DLIF IBD 10x22x50, 12 deg
• B678523462S0: DLIF IBD 8x22x50, 12 deg
• B678523461S0: DLIF IBD 16x22x45, 12 deg
• B678523460S0: DLIF IBD 14x22x45, 12 deg
• B678523459S0: DLIF IBD 12x22x45, 12 deg
• B678523458S0: DLIF IBD 10x22x45, 12 deg
• B678523457S0: DLIF IBD 8x22x45, 12 deg
• B678523456S0: DLIF IBD 16x22x40, 12 deg
• B678523455S0: DLIF IBD 14x22x40, 12 deg
• B678523454S0: DLIF IBD 12x22x40, 12 deg