FDA.reportPublic FDA data

ZSFab PLIF Universal Instrument

Primary DI
00810136254679
Brand
ZSFab PLIF Universal Instrument
Company
Zsfab, Inc.
Model
YZM100122
Device description
Nerve Retractor 6
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
00810136254679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810136254679008101362546798101362546790810136254679

GMDN Terms#

Term, Definition table
TermDefinition
Nerve/vessel retractorA hand-held, non-self-retaining surgical instrument intended to be used for retracting a nerve, tendon, or blood vessel to separate it from the surrounding tissue primarily to allow access to other tissues during a surgical intervention. It is a shaft-like metallic instrument with a blunt bulbous or rounded hook-like retraction tip at the distal end, and a handle at the proximal end. It is available in a variety of designs such as, curved, right-angled, or 45 degree angled. 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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10810128464144Tendon Stripper, ClosedT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
10810128464151Tendon Stripper, OpenT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-10-20
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
B504OMBMAS90006S0BrasselerProvisionLXH2026-10-20
B504OMBMAS90007S0BrasselerProvisionLXH2026-10-20
B504OMBMAS90008S0BrasselerProvisionLXH2026-10-20
B504OMBMLS900040BrasselerProvisionLXH2026-10-20
B504OMBR2544001110BrasselerProvisionLXH2026-10-20
B504OMBR9505023020BrasselerProvisionLXH2026-10-20
B504OMBR9505023030BrasselerProvisionLXH2026-10-20
B504OMDP86011710BrasselerProvisionLXH2026-10-20
B504OMST60070031000BrasselerProvisionLXH2026-10-20
B504OMST60070031500BrasselerProvisionLXH2026-10-20
B504OMST60071031100BrasselerProvisionLXH2026-10-20
B504OMST60071041500BrasselerProvisionLXH2026-10-20
B504OMZB005901020000BrasselerProvisionLXH2026-10-20
00824846013082Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-19
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
00810161900305EARP, TRIAL 22X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900312EARP, TRIAL 22X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900329EARP, TRIAL 22X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161900336EARP, TRIAL 22X35X14 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901418EARP TRIAL 22x40x10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16
00810161901425EARP TRIAL 22x40x12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-16