FDA.reportPublic FDA data

ZSFab PLIF Universal Instrument

Primary DI
00810136254624
Brand
ZSFab PLIF Universal Instrument
Company
Zsfab, Inc.
Model
YZM100111
Device description
Reamer 11
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
00810136254624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810136254624008101362546248101362546240810136254624

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. 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
00810216325312ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16160610-LZSAC16160610-L2026-08-13
00810216325329ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16160610-MZSAC16160610-M2026-08-13
00810216325336ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16160610-HZSAC16160610-H2026-08-13
00810216325343ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16160710-LZSAC16160710-L2026-08-13
00810216325350ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16160710-MZSAC16160710-M2026-08-13
00810216325367ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16160710-HZSAC16160710-H2026-08-13
00810216325374ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16160810-LZSAC16160810-L2026-08-13
00810216325381ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16160810-MZSAC16160810-M2026-08-13
00810216325404ZSAlign Cervical Interbody System-Spacer-WedgevZSAC16160910-LZSAC16160910-L2026-08-13
00810216325411ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16160910-MZSAC16160910-M2026-08-13
00810216325428ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16160910-HZSAC16160910-H2026-08-13
00810216325435ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16161010-LZSAC16161010-L2026-08-13
00810216325459ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16161010-HZSAC16161010-H2026-08-13
00810216325473ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16161110-MZSAC16161110-M2026-08-13
00810216325480ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16161110-HZSAC16161110-H2026-08-13
00810216325497ZSAlign Cervical Interbody System-Spacer-WedgeZSAC16161210-LZSAC16161210-L2026-08-13
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

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