ZSFab Lumbar Interbody System

GUDID 00850035165423

Lumbar-P-TLIF 24Dx10Wx09Hx6°

Zsfab, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: 00850035165423
• NIH Device Record Key: a1aa4425-7c47-48c7-9ba9-3b880aef3c1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZSFab Lumbar Interbody System
• Version Model Number: 24100906
• Company DUNS: 105224126
• Company Name: Zsfab, 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: 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

• Depth: 24 Millimeter
• Width: 10 Millimeter
• Height: 9 Millimeter
• Angle: 6 degree
• Depth: 24 Millimeter
• Width: 10 Millimeter
• Height: 9 Millimeter
• Angle: 6 degree
• Depth: 24 Millimeter
• Width: 10 Millimeter
• Height: 9 Millimeter
• Angle: 6 degree
• Depth: 24 Millimeter
• Width: 10 Millimeter
• Height: 9 Millimeter
• Angle: 6 degree
• Depth: 24 Millimeter
• Width: 10 Millimeter
• Height: 9 Millimeter
• Angle: 6 degree
• Depth: 24 Millimeter
• Width: 10 Millimeter
• Height: 9 Millimeter
• Angle: 6 degree
• Depth: 24 Millimeter
• Width: 10 Millimeter
• Height: 9 Millimeter
• Angle: 6 degree
• Depth: 24 Millimeter
• Width: 10 Millimeter
• Height: 9 Millimeter
• Angle: 6 degree
• Depth: 24 Millimeter
• Width: 10 Millimeter
• Height: 9 Millimeter
• Angle: 6 degree
• Depth: 24 Millimeter
• Width: 10 Millimeter
• Height: 9 Millimeter
• Angle: 6 degree
• Depth: 24 Millimeter
• Width: 10 Millimeter
• Height: 9 Millimeter
• Angle: 6 degree
• Depth: 24 Millimeter
• Width: 10 Millimeter
• Height: 9 Millimeter
• Angle: 6 degree
• Depth: 24 Millimeter
• Width: 10 Millimeter
• Height: 9 Millimeter
• Angle: 6 degree
• Depth: 24 Millimeter
• Width: 10 Millimeter
• Height: 9 Millimeter
• Angle: 6 degree
• Depth: 24 Millimeter
• Width: 10 Millimeter
• Height: 9 Millimeter
• Angle: 6 degree
• Depth: 24 Millimeter
• Width: 10 Millimeter
• Height: 9 Millimeter
• Angle: 6 degree
• Depth: 24 Millimeter
• Width: 10 Millimeter
• Height: 9 Millimeter
• Angle: 6 degree
• Depth: 24 Millimeter
• Width: 10 Millimeter
• Height: 9 Millimeter
• Angle: 6 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850035165423 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221858

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: 2025-05-20
• Device Publish Date: 2025-05-12

On-Brand Devices [ZSFab Lumbar Interbody System]

• 00810136253191: Lumbar-P-TLIF 28Dx10Wx14Hx6°
• 00810136253184: Lumbar-P-TLIF 28Dx10Wx13Hx6°
• 00810136253177: Lumbar-P-TLIF 28Dx10Wx12Hx6°
• 00810136253160: Lumbar-P-TLIF 28Dx10Wx11Hx6°
• 00810136253153: Lumbar-P-TLIF 28Dx10Wx10Hx6°
• 00810136253146: Lumbar-P-TLIF 28Dx10Wx09Hx6°
• 00810136253139: Lumbar-P-TLIF 28Dx10Wx08Hx6°
• 00810136253122: Lumbar-P-TLIF 28Dx10Wx14Hx0°
• 00810136253115: Lumbar-P-TLIF 28Dx10Wx13Hx0°
• 00810136253108: Lumbar-P-TLIF 28Dx10Wx12Hx0°
• 00810136253092: Lumbar-P-TLIF 28Dx10Wx11Hx0°
• 00810136253085: Lumbar-P-TLIF 28Dx10Wx10Hx0°
• 00810136253078: Lumbar-P-TLIF 28Dx10Wx09Hx0°
• 00810136253061: Lumbar-P-TLIF 28Dx10Wx08Hx0°
• 00810136253054: Lumbar-P-TLIF 28Dx10Wx14Hx6°
• 00810136253047: Lumbar-P-TLIF 24Dx10Wx13Hx6°
• 00810136253030: Lumbar-P-TLIF 24Dx10Wx12Hx6°
• 00810136253023: Lumbar-P-TLIF 24Dx10Wx11Hx6°
• 00810136253016: Lumbar-P-TLIF 24Dx10Wx10Hx6°
• 00810136253009: Lumbar-P-TLIF 24Dx10Wx09Hx6°
• 00810136252996: Lumbar-P-TLIF 24Dx10Wx08Hx6°
• 00810136252989: Lumbar-P-TLIF 24Dx10Wx14Hx0°
• 00810136252972: Lumbar-P-TLIF 24Dx10Wx13Hx0°
• 00810136252965: Lumbar-P-TLIF 24Dx10Wx12Hx0°
• 00810136252958: Lumbar-P-TLIF 24Dx10Wx11Hx0°
• 00810136252941: Lumbar-P-TLIF 24Dx10Wx10Hx0°
• 00810136252934: Lumbar-P-TLIF 24Dx10Wx09Hx0°
• 00810136252927: Lumbar-P-TLIF 24Dx10Wx08Hx0°
• 00810136252910: Lumbar-P-TLIF 20Dx10Wx14Hx6°
• 00810136252903: Lumbar-P-TLIF 20Dx10Wx13Hx6°
• 00810136252897: Lumbar-P-TLIF 20Dx10Wx12Hx6°
• 00810136252880: Lumbar-P-TLIF 20Dx10Wx11Hx6°
• 00810136252873: Lumbar-P-TLIF 20Dx10Wx10Hx6°
• 00810136252866: Lumbar-P-TLIF 20Dx10Wx09Hx6°
• 00810136252859: Lumbar-P-TLIF 20Dx10Wx08Hx6°
• 00810136252842: Lumbar-P-TLIF 20Dx10Wx14Hx0°
• 00810136252835: Lumbar-P-TLIF 20Dx10Wx13Hx0°
• 00810136252828: Lumbar-P-TLIF 20Dx10Wx12Hx0°
• 00810136252811: Lumbar-P-TLIF 20Dx10Wx11Hx0°
• 00810136252804: Lumbar-P-TLIF 20Dx10Wx10Hx0°
• 00810136252798: Lumbar-P-TLIF 20Dx10Wx09Hx0°
• 00810136252781: Lumbar-P-TLIF 20Dx10Wx08Hx0°
• 00810136252477: Lumbar-TLIF 31Dx12Wx14Hx8°
• 00810136252460: Lumbar-TLIF 31Dx12Wx13Hx8°
• 00810136252453: Lumbar-TLIF 31Dx12Wx12Hx8°
• 00810136252446: Lumbar-TLIF 31Dx12Wx11Hx8°
• 00810136252439: Lumbar-TLIF 31Dx12Wx10Hx8°
• 00810136252422: Lumbar-TLIF 31Dx12Wx09Hx8°
• 00810136252415: Lumbar-TLIF 31Dx12Wx08Hx8°
• 00810136252408: Lumbar-TLIF 31Dx12Wx14Hx4°