FDA.report

ZSFab Lumbar Interbody System

Primary DI
00810136258752
Brand
ZSFab Lumbar Interbody System
Company
Zsfab, Inc.
Model
LPT32110700R
Device description
Lumbar-P-TLIF32Dx11Wx07Hx00°_R
Published
2025-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810136258752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810136258752008101362587528101362587520810136258752

GMDN Terms

TermDefinition
Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.

Device Sizes

TypeValueUnit
Angle0degree
Depth32Millimeter
Height7Millimeter
Width11Millimeter

Sterilization Methods

Method

Regulatory Flags

DUNS number
105224126
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810136256666ZSFab Lumbar Interbody SystemLPT24101210R2026-02-11
00810136257274ZSFab Lumbar Interbody SystemLPT28090700R2026-02-11
00810136254938ZSFab Lumbar Interbody SystemLPT20100800R2025-10-23
00810136254945ZSFab Lumbar Interbody SystemLPT20100900R2025-10-23
00810136254952ZSFab Lumbar Interbody SystemLPT20101000R2025-10-23
00810136254969ZSFab Lumbar Interbody SystemLPT20101100R2025-10-23
00810136254976ZSFab Lumbar Interbody SystemLPT20101200R2025-10-23
00810136254983ZSFab Lumbar Interbody SystemLPT20101300R2025-10-23
00810136254990ZSFab Lumbar Interbody SystemLPT20101400R2025-10-23
00810136255003ZSFab Lumbar Interbody SystemLPT20101500R2025-10-23
00810136255010ZSFab Lumbar Interbody SystemLPT20101600R2025-10-23
00810136255027ZSFab Lumbar Interbody SystemLPT20101700R2025-10-23
00810136255034ZSFab Lumbar Interbody SystemLPT20110800R2025-10-23
00810136255041ZSFab Lumbar Interbody SystemLPT20110900R2025-10-23
00810136255058ZSFab Lumbar Interbody SystemLPT20111000R2025-10-23
00810136255065ZSFab Lumbar Interbody SystemLPT20111100R2025-10-23
00810136255072ZSFab Lumbar Interbody SystemLPT20111200R2025-10-23
00810136255089ZSFab Lumbar Interbody SystemLPT20111300R2025-10-23
00810136255096ZSFab Lumbar Interbody SystemLPT20111400R2025-10-23
00810136255102ZSFab Lumbar Interbody SystemLPT20111500R2025-10-23

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