FDA.reportPublic FDA data

ZSFab Customized PLIF Instrument

Primary DI
00810136254228
Brand
ZSFab Customized PLIF Instrument
Company
Zsfab, Inc.
Model
YZM100104
Device description
Wrench
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
00810136254228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810136254228008101362542288101362542280810136254228

GMDN Terms#

Term, Definition table
TermDefinition
Surgical torque wrench, reusableA hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000880118MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-23
00842528130056OSTEOMEDOSTEOMED LLCLXH2026-10-23
00888867550391Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550407Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550414Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550421Arthrex®ARTHREX, INC.LXH2026-10-23
04251631412144BEE PLIFNGMedical GmbHLXH2026-10-23
M739153997700Cross Connector DriverCAPTIVA SPINE, INC.LXH2026-10-23
M739153998800Cross Connector Counter TorqueCAPTIVA SPINE, INC.LXH2026-10-23
M739243501000Blade DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243502000Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243503000In-Line HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739243504000Tissue DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243505000Tissue ProtectorCAPTIVA SPINE, INC.LXH2026-10-23
M739243506000Adjustable Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243507000Impaction SleeveCAPTIVA SPINE, INC.LXH2026-10-23
M739243508000Self-Feeding DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739243509000Implant Filling TubeCAPTIVA SPINE, INC.LXH2026-10-23
M739243511000Plunger RodCAPTIVA SPINE, INC.LXH2026-10-23
M739243512000Cannulated Drill, 7mmCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151066mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151077mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151088mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151099mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511010mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511111mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511212mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739983101200Coupling - Square ConnectCAPTIVA SPINE, INC.LXH2026-10-23
M739983240300Impaction T-HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739985202530Marking PinCAPTIVA SPINE, INC.LXH2026-10-23