FDA.reportPublic FDA data

ZSFab PLIF Universal Instrument

Primary DI
00810136254778
Brand
ZSFab PLIF Universal Instrument
Company
Zsfab, Inc.
Model
YZM100128
Device description
Bone Graft Funnel
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810136254778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810136254778008101362547788101362547780810136254778

GMDN Terms#

Term, Definition table
TermDefinition
Bone graft funnelA device designed to deliver bone graft filling material (autologous, allogeneic, xenogeneic, or synthetic) during an orthopaedic procedure to enable the filling of bone gaps intended to be fused. It is a funnel-shaped device; the funnel being bowl-shaped with the ability to hold back the filling material depending upon the angle of tilt applied by the surgeon, and a long, thin tube that can be inserted into the site to be filled, e.g., a cancellous bone graft being discharged into the posterior disc space of a vertebra. An orthopaedic graft inserter can be pushed down the funnel tube to press the graft material into the site. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
105224126
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810216329235ZSAlign Cervical Interbody System-ScrewZSAC0635014ZSAC06350142026-10-14
00810216329242ZSAlign Cervical Interbody System-ScrewZSAC0635016ZSAC06350162026-10-14
00810216329259ZSAlign Cervical Interbody System-ScrewZSAC0635018ZSAC06350182026-10-14
00810216329266ZSAlign Cervical Interbody System-ScrewZSAC0635020ZSAC06350202026-10-14
00810216329273ZSAlign Cervical Interbody System-ScrewZSAC0640012ZSAC06400122026-10-14
00810216329280ZSAlign Cervical Interbody System-ScrewZSAC0640014ZSAC06400142026-10-14
00810216329297ZSAlign Cervical Interbody System-ScrewZSAC0640016ZSAC06400162026-10-14
00810216329303ZSAlign Cervical Interbody System-ScrewZSAC0640018ZSAC06400182026-10-14
00810216329310ZSAlign Cervical Interbody System-ScrewZSAC0640020ZSAC06400202026-10-14
00810216329334ZSAlign Cervical Interbody System-ScrewZSAC0735014ZSAC07350142026-10-14
00810216329341ZSAlign Cervical Interbody System-ScrewZSAC0735016ZSAC07350162026-10-14
00810216329358ZSAlign Cervical Interbody System-ScrewZSAC0735018ZSAC07350182026-10-14
00810216329372ZSAlign Cervical Interbody System-ScrewZSAC0740012ZSAC07400122026-10-14
00810216329389ZSAlign Cervical Interbody System-ScrewZSAC0740014ZSAC07400142026-10-14
00810216329396ZSAlign Cervical Interbody System-ScrewZSAC0740016ZSAC07400162026-10-14
00810216329402ZSAlign Cervical Interbody System-ScrewZSAC0740018ZSAC07400182026-10-14
00810216329419ZSAlign Cervical Interbody System-ScrewZSAC0740020ZSAC07400202026-10-14
00810236520001ZSFab Lumbar Interbody SystemLPT20100810NR2026-10-10
00810236520018ZSFab Lumbar Interbody SystemLPT20110810NR2026-10-10
00810236520025ZSFab Lumbar Interbody SystemLPT20101015NR2026-10-10

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10810128464168Tunnel Depth ProbeT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10840642149838Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
10840642149845Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.LXH2026-10-20
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00850078396440SYNQ Single-Use Instrument System(1066)Eca Medical InstrumentsLXH2026-10-19
00889024715295Persona Extended V/V Guide Assembly (MFS)Zimmer, Inc.LXH2026-10-19
08809986489807LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-19
00810111228671Cut GuideTreace Medical Concepts, Inc.LXH2026-10-16
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