ZSFab Cervical Interbody System

GUDID 08500351650067

Cervical 12Dx14Wx07HX7°

Zsfab, Inc.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 08500351650067
• NIH Device Record Key: 7b7ba019-6a51-48dc-a934-ada0894b8170
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZSFab Cervical Interbody System
• Version Model Number: 12140707
• 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: 12 Millimeter
• Width: 14 Millimeter
• Height: 7 Millimeter
• Angle: 7 degree
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 7 Millimeter
• Angle: 7 degree
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 7 Millimeter
• Angle: 7 degree
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 7 Millimeter
• Angle: 7 degree
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 7 Millimeter
• Angle: 7 degree
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 7 Millimeter
• Angle: 7 degree
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 7 Millimeter
• Angle: 7 degree
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 7 Millimeter
• Angle: 7 degree
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 7 Millimeter
• Angle: 7 degree
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 7 Millimeter
• Angle: 7 degree
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 7 Millimeter
• Angle: 7 degree
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 7 Millimeter
• Angle: 7 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	08500351650067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202488

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

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: 2022-12-09
• Device Publish Date: 2022-12-01

On-Brand Devices [ZSFab Cervical Interbody System]

• 08500351650005: Cervical 12Dx14Wx06Hx0°
• 08500351650197: Cervical 14Dx16Wx10HX7°
• 08500351650180: Cervical 14Dx16Wx09HX7°
• 08500351650173: Cervical 14Dx16Wx08HX7°
• 08500351650166: Cervical 14Dx16Wx07HX7°
• 08500351650159: Cervical 14Dx16Wx06HX7°
• 08500351650142: Cervical 14Dx16Wx10HX0°
• 08500351650135: Cervical 14Dx16Wx09HX0°
• 08500351650128: Cervical 14Dx16Wx08HX0°
• 08500351650111: Cervical 14Dx16Wx07HX0°
• 08500351650104: Cervical 14Dx16Wx06HX0°
• 08500351650098: Cervical 12Dx14Wx10HX7°
• 08500351650081: Cervical 12Dx14Wx09HX7°
• 08500351650074: Cervical 12Dx14Wx08HX7°
• 08500351650067: Cervical 12Dx14Wx07HX7°
• 08500351650050: Cervical 12Dx14Wx06HX7°
• 08500351650043: Cervical 12Dx14Wx10HX0°
• 08500351650036: Cervical 12Dx14Wx09HX0°
• 08500351650029: Cervical 12Dx14Wx08HX0°
• 08500351650012: Cervical 12Dx14Wx07HX0°
• 00850035165904: Cervical 12Dx14Wx05Hx0°
• 00850035165997: Cervical 12Dx14Wx08Hx10°
• 00850035165980: Cervical 12Dx14Wx07Hx10°
• 00850035165973: Cervical 12Dx14Wx06Hx10°
• 00850035165966: Cervical 12Dx14Wx05Hx10°
• 00850035165959: Cervical 12Dx14Wx12Hx7°
• 00850035165942: Cervical 12Dx14Wx11Hx7°
• 00850035165935: Cervical 12Dx14Wx05Hx7°
• 00850035165928: Cervical 12Dx14Wx12Hx0°
• 00850035165911: Cervical 12Dx14Wx11Hx0°
• 00810136250763: Cervical 16Dx18Wx12Hx20°
• 00810136250756: Cervical 16Dx18Wx11Hx20°
• 00810136250749: Cervical 16Dx18Wx10Hx20°
• 00810136250732: Cervical 16Dx18Wx09Hx20°
• 00810136250725: Cervical 16Dx18Wx08Hx20°
• 00810136250718: Cervical 16Dx18Wx12Hx15°
• 00810136250701: Cervical 16Dx18Wx11Hx15°
• 00810136250695: Cervical 16Dx18Wx10Hx15°
• 00810136250688: Cervical 16Dx18Wx09Hx15°
• 00810136250671: Cervical 16Dx18Wx08Hx15°
• 00810136250664: Cervical 16Dx18Wx07Hx15°
• 00810136250657: Cervical 16Dx18Wx12Hx10°
• 00810136250640: Cervical 16Dx18Wx11Hx10°
• 00810136250633: Cervical 16Dx18Wx10Hx10°
• 00810136250626: Cervical 16Dx18Wx09Hx10°
• 00810136250619: Cervical 16Dx18Wx08Hx10°
• 00810136250602: Cervical 16Dx18Wx07Hx10°
• 00810136250596: Cervical 16Dx18Wx06Hx10°
• 00810136250589: Cervical 16Dx18Wx12Hx7°
• 00810136250572: Cervical 16Dx18Wx11Hx7°