ZSFab Cervical Interbody System

GUDID 00810136250572

Cervical 16Dx18Wx11Hx7°

Zsfab, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: 00810136250572
• NIH Device Record Key: a3ec5cbb-0a9d-4d36-844a-d39c0d3a0bc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZSFab Cervical Interbody System
• Version Model Number: 16181107
• 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: 16 Millimeter
• Width: 18 Millimeter
• Height: 11 Millimeter
• Angle: 7 degree
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 11 Millimeter
• Angle: 7 degree
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 11 Millimeter
• Angle: 7 degree
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 11 Millimeter
• Angle: 7 degree
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 11 Millimeter
• Angle: 7 degree
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 11 Millimeter
• Angle: 7 degree
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 11 Millimeter
• Angle: 7 degree
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 11 Millimeter
• Angle: 7 degree
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 11 Millimeter
• Angle: 7 degree
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 11 Millimeter
• Angle: 7 degree
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 11 Millimeter
• Angle: 7 degree
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 11 Millimeter
• Angle: 7 degree
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 11 Millimeter
• Angle: 7 degree
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 11 Millimeter
• Angle: 7 degree
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 11 Millimeter
• Angle: 7 degree
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 11 Millimeter
• Angle: 7 degree
• Depth: 16 Millimeter
• Width: 18 Millimeter
• Height: 11 Millimeter
• Angle: 7 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810136250572 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232150

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: 2024-01-25
• Device Publish Date: 2024-01-17

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°