FDA.reportPublic FDA data

ZSFab Lumbar Interbody System

Primary DI
00810136258769
Brand
ZSFab Lumbar Interbody System
Company
Zsfab, Inc.
Model
LPT32110800R
Device description
Lumbar-P-TLIF32Dx11Wx08Hx00°_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
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810136258769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810136258769008101362587698101362587690810136258769

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Angle0degree
Depth32Millimeter
Height8Millimeter
Width11Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
105224126
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810136254204ZSFab Customized PLIF Instrument JZM1000012026-04-30
00810136254211ZSFab Customized PLIF Instrument JZM1000022026-04-30
00810136254228ZSFab Customized PLIF Instrument YZM1001042026-04-30
00810136254235ZSFab Customized PLIF Instrument YZM1001272026-04-30
00810136254242ZSFab Customized PLIF Instrument YZM1001032026-04-30
00810136254259ZSFab Customized PLIF Instrument YZM1001252026-04-30
00810136254266ZSFab Customized PLIF Instrument YZM1010382026-04-30
00810136254273ZSFab Customized PLIF Instrument YZM1010402026-04-30
00810136254280ZSFab Customized PLIF Instrument YZM1010422026-04-30
00810136254297ZSFab Customized PLIF Instrument YZM1010442026-04-30
00810136254303ZSFab Customized PLIF Instrument YZM1010252026-04-30
00810136254310ZSFab Customized PLIF Instrument YZM1010262026-04-30
00810136254327ZSFab Customized PLIF Instrument YZM1010272026-04-30
00810136254334ZSFab Customized PLIF Instrument YZM1010282026-04-30
00810136254341ZSFab Customized PLIF Instrument YZM1010292026-04-30
00810136254358ZSFab Customized PLIF Instrument YZM1010012026-04-30
00810136254365ZSFab Customized PLIF Instrument YZM1010022026-04-30
00810136254372ZSFab Customized PLIF Instrument YZM1010032026-04-30
00810136254389ZSFab Customized PLIF Instrument YZM1010072026-04-30
00810136254396ZSFab Customized PLIF Instrument YZM1010082026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157075859ZAVATION INSERTERZavation LLCMAX2026-05-27
00810166522366X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
00810166522373X-PACEXPANDING INNOVATIONS, INC.MAX2026-05-27
B70712535005S0Dual X Graft Tamp ShortAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010130DUALXS T/PLIF 15 DEG x 9-12MMAMPLIFY SURGICAL, INC.MAX2026-05-27
B707129410010200DUALXS T/PLIF 18 DEG x 10-13MMAMPLIFY SURGICAL, INC.MAX2026-05-27
07613153046196AVS PLStryker CorporationMAX2015-09-14
07613153046202AVS PLStryker CorporationMAX2015-09-14
07613153046219AVS PLStryker CorporationMAX2015-09-14
07613153046233AVS PLStryker CorporationMAX2015-09-14
07613153046301AVS PLStryker CorporationMAX2015-09-14
07613153046325AVS PLStryker CorporationMAX2015-09-14
07613153046332AVS PLStryker CorporationMAX2015-09-14
07613153046356AVS PLStryker CorporationMAX2015-09-14
07613153046363AVS PLStryker CorporationMAX2015-09-14
07613153046394AVS TLStryker CorporationMAX2015-09-14
07613153046400AVS TLStryker CorporationMAX2015-09-14
07613153046417AVS TLStryker CorporationMAX2015-09-14
07613153046424AVS TLStryker CorporationMAX2015-09-14
07613153046431AVS TLStryker CorporationMAX2015-09-14
07613153046448AVS TLStryker CorporationMAX2015-09-14
07613153046455AVS TLStryker CorporationMAX2015-09-14
07613153046462AVS TLStryker CorporationMAX2015-09-14
07613153046479AVS TLStryker CorporationMAX2015-09-14
07613153046486AVS TLStryker CorporationMAX2015-09-14
07613153046493AVS TLStryker CorporationMAX2015-09-14
07613153046509AVS TLStryker CorporationMAX2015-09-14
07613153046530AVS TLStryker CorporationMAX2015-09-14
07613153046547AVS TLStryker CorporationMAX2015-09-14
07613153046578AVS TLStryker CorporationMAX2015-09-14