FDA.reportPublic FDA data

ZSFab Customized PLIF Instrument

Primary DI
00810136254365
Brand
ZSFab Customized PLIF Instrument
Company
Zsfab, Inc.
Model
YZM101002
Device description
Nerve Retractor 5mm
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
00810136254365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810136254365008101362543658101362543650810136254365

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
00810216325442ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16161010-MZSAC16161010-M2026-08-17
00810216325466ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16161110-LZSAC16161110-L2026-08-17
00810216325800ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16180800-MZSAC16180800-M2026-08-17
00810216325817ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16180800-HZSAC16180800-H2026-08-17
00810216325824ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16180900-LZSAC16180900-L2026-08-17
00810216325831ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16180900-MZSAC16180900-M2026-08-17
00810216325848ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16180900-HZSAC16180900-H2026-08-17
00810216325855ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16181000-LZSAC16181000-L2026-08-17
00810216325862ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16181000-MZSAC16181000-M2026-08-17
00810216325879ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16181000-HZSAC16181000-H2026-08-17
00810216325886ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16181100-LZSAC16181100-L2026-08-17
00810216325893ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16181100-MZSAC16181100-M2026-08-17
00810216325909ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16181100-HZSAC16181100-H2026-08-17
00810216325916ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16181200-LZSAC16181200-L2026-08-17
00810216325923ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16181200-MZSAC16181200-M2026-08-17
00810216325930ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16181200-HZSAC16181200-H2026-08-17
00810216325947ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16180507-LZSAC16180507-L2026-08-17
00810216325954ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16180507-MZSAC16180507-M2026-08-17
00810216325961ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16180507-HZSAC16180507-H2026-08-17
00810216325978ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16180607-LZSAC16180607-L2026-08-17

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