ZSFab Lumbar Interbody System

GUDID 00850035165287

Lumbar-P-TLIF 20Dx10Wx09Hx6°

Zsfab, Inc.

Metallic spinal interbody fusion cage

Primary Device ID	00850035165287
NIH Device Record Key	66df9076-de4f-423d-863c-c4dcb559b32b
Commercial Distribution Status	In Commercial Distribution
Brand Name	ZSFab Lumbar Interbody System
Version Model Number	20100906
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	20 Millimeter
Width	10 Millimeter
Height	9 Millimeter
Angle	6 degree
Depth	20 Millimeter
Width	10 Millimeter
Height	9 Millimeter
Angle	6 degree
Depth	20 Millimeter
Width	10 Millimeter
Height	9 Millimeter
Angle	6 degree
Depth	20 Millimeter
Width	10 Millimeter
Height	9 Millimeter
Angle	6 degree
Depth	20 Millimeter
Width	10 Millimeter
Height	9 Millimeter
Angle	6 degree
Depth	20 Millimeter
Width	10 Millimeter
Height	9 Millimeter
Angle	6 degree
Depth	20 Millimeter
Width	10 Millimeter
Height	9 Millimeter
Angle	6 degree
Depth	20 Millimeter
Width	10 Millimeter
Height	9 Millimeter
Angle	6 degree
Depth	20 Millimeter
Width	10 Millimeter
Height	9 Millimeter
Angle	6 degree
Depth	20 Millimeter
Width	10 Millimeter
Height	9 Millimeter
Angle	6 degree
Depth	20 Millimeter
Width	10 Millimeter
Height	9 Millimeter
Angle	6 degree
Depth	20 Millimeter
Width	10 Millimeter
Height	9 Millimeter
Angle	6 degree
Depth	20 Millimeter
Width	10 Millimeter
Height	9 Millimeter
Angle	6 degree
Depth	20 Millimeter
Width	10 Millimeter
Height	9 Millimeter
Angle	6 degree
Depth	20 Millimeter
Width	10 Millimeter
Height	9 Millimeter
Angle	6 degree
Depth	20 Millimeter
Width	10 Millimeter
Height	9 Millimeter
Angle	6 degree
Depth	20 Millimeter
Width	10 Millimeter
Height	9 Millimeter
Angle	6 degree
Depth	20 Millimeter
Width	10 Millimeter
Height	9 Millimeter
Angle	6 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850035165287 [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°