FDA.reportPublic FDA data

ZSFab Lumbar Interbody System

Primary DI
00810236520094
Brand
ZSFab Lumbar Interbody System
Company
Zsfab, Inc.
Model
LPT24100810NR
Device description
Lumbar-P-TLIF24Dx10Wx08Hx10°_No Rotation
Published
2026-10-10
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

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
00810236520094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810236520094008102365200948102365200940810236520094

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
Angle0
Depth0
Height0
Width0

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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810236520001ZSFab Lumbar Interbody SystemLPT20100810NR2026-10-10
00810236520018ZSFab Lumbar Interbody SystemLPT20110810NR2026-10-10
00810236520025ZSFab Lumbar Interbody SystemLPT20101015NR2026-10-10
00810236520032ZSFab Lumbar Interbody SystemLPT20111015NR2026-10-10
00810236520049ZSFab Lumbar Interbody SystemLPT20101120NR2026-10-10
00810236520056ZSFab Lumbar Interbody SystemLPT20111120NR2026-10-10
00810236520063ZSFab Lumbar Interbody SystemLPT24100600NR2026-10-10
00810236520070ZSFab Lumbar Interbody SystemLPT24100706NR2026-10-10
00810236520087ZSFab Lumbar Interbody SystemLPT24100806NR2026-10-10
00810236520100ZSFab Lumbar Interbody SystemLPT24100910NR2026-10-10
00810236520117ZSFab Lumbar Interbody SystemLPT24101015NR2026-10-10
00810236520124ZSFab Lumbar Interbody SystemLPT24101120NR2026-10-10
00810236520131ZSFab Lumbar Interbody SystemLPT24101220NR2026-10-10
00810236520148ZSFab Lumbar Interbody SystemLPT24110600NR2026-10-10
00810236520155ZSFab Lumbar Interbody SystemLPT24110706NR2026-10-10
00810236520162ZSFab Lumbar Interbody SystemLPT24110806NR2026-10-10
00810236520179ZSFab Lumbar Interbody SystemLPT24110810NR2026-10-10
00810236520186ZSFab Lumbar Interbody SystemLPT24110910NR2026-10-10
00810236520193ZSFab Lumbar Interbody SystemLPT24111015NR2026-10-10
00810236520209ZSFab Lumbar Interbody SystemLPT24111120NR2026-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810236520001ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520018ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520025ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520032ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520049ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520056ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520063ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520070ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520087ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520100ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520117ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520124ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520131ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520148ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520155ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520162ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520179ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520186ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520193ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520209ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520216ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520223ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520230ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520247ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520254ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520261ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520278ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520285ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520292ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10
00810236520308ZSFab Lumbar Interbody SystemZsfab, Inc.MAX2026-10-10