FDA.reportPublic FDA data

ZSFab Lumbar Interbody System

Primary DI
00810136259476
Brand
ZSFab Lumbar Interbody System
Company
Zsfab, Inc.
Model
LPT32091615R
Device description
Lumbar-P-TLIF32Dx09Wx16Hx15°_R
Published
2025-12-31
Public version status
Update
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221858000
K252610000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221858000ZSFab Lumbar Interbody SystemZsfab, Inc.2022-10-14MAX
K252610000ZSFab Lumbar Interbody SystemZsfab, Inc.2025-11-25MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810136259476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810136259476008101362594768101362594760810136259476

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
Angle15degree
Depth32Millimeter
Height16Millimeter
Width9Millimeter

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
00840283403460LumiVy™VY SPINE LLCMAX2026-06-05
08800043912870N/ATDM Co., Ltd.MAX2026-06-02
08800043912887N/ATDM Co., Ltd.MAX2026-06-02
08800043912894N/ATDM Co., Ltd.MAX2026-06-02
08800043912900N/ATDM Co., Ltd.MAX2026-06-02
08800043912917N/ATDM Co., Ltd.MAX2026-06-02
08800043912924N/ATDM Co., Ltd.MAX2026-06-02
08800043912931N/ATDM Co., Ltd.MAX2026-06-02
08800043912948N/ATDM Co., Ltd.MAX2026-06-02
08800043912955N/ATDM Co., Ltd.MAX2026-06-02
08800043912962N/ATDM Co., Ltd.MAX2026-06-02
08800043912979N/ATDM Co., Ltd.MAX2026-06-02
08800043912986N/ATDM Co., Ltd.MAX2026-06-02
08800043912993N/ATDM Co., Ltd.MAX2026-06-02
08800043913006N/ATDM Co., Ltd.MAX2026-06-02
08800043913013N/ATDM Co., Ltd.MAX2026-06-02
08800043913020N/ATDM Co., Ltd.MAX2026-06-02
08800043913037N/ATDM Co., Ltd.MAX2026-06-02
08800043913044N/ATDM Co., Ltd.MAX2026-06-02
08800043913051N/ATDM Co., Ltd.MAX2026-06-02
08800043913068N/ATDM Co., Ltd.MAX2026-06-02
08800043913075N/ATDM Co., Ltd.MAX2026-06-02
08800043964183N/ATDM Co., Ltd.MAX2026-06-02
08800043964190N/ATDM Co., Ltd.MAX2026-06-02
08800043964206N/ATDM Co., Ltd.MAX2026-06-02
08800043964213N/ATDM Co., Ltd.MAX2026-06-02
08800043964220N/ATDM Co., Ltd.MAX2026-06-02
08800043964237N/ATDM Co., Ltd.MAX2026-06-02
08800043964244N/ATDM Co., Ltd.MAX2026-06-02
08800043964251N/ATDM Co., Ltd.MAX2026-06-02