FDA.reportPublic FDA data

ZSFab PLIF Universal Instrument

Primary DI
00810136254655
Brand
ZSFab PLIF Universal Instrument
Company
Zsfab, Inc.
Model
YZM100114
Device description
Reamer 14
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
00810136254655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810136254655008101362546558101362546550810136254655

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
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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Primary DI, Brand, Company table
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00888867620629Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620636Arthrex®ARTHREX, INC.LXH2026-10-01
00888867620643Arthrex®ARTHREX, INC.LXH2026-10-01
M7401001380OptiLIF Endo, Direct Visualization SystemSPINEOLOGY INC.LXH2026-10-01
00840606191425PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191432PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191449PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00840606191456PrimusSPINAL ELEMENTS, INC.LXH2026-09-30
00810017915668SABER-XA, Trial InserterELEVATION SPINE, INC.LXH2026-09-29
00810017916030SABER-XA Straight Awl, Self-GuidedELEVATION SPINE, INC.LXH2026-09-29
00810055525300Onyx 4.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525317Onyx 5.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525324Onyx 6.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525331Onyx 7.5mm Cannulated TapSi-Bone Inc.LXH2026-09-29
00810055525348Onyx 4.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
00810055525355Onyx 5.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
00810055525362Onyx 6.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
00810055525379Onyx 7.5MM Awl Tip TapSi-Bone Inc.LXH2026-09-29
00810055525386Onyx Feeler ProbeSi-Bone Inc.LXH2026-09-29
00810055525393Onyx Straight ProbeSi-Bone Inc.LXH2026-09-29
00810055525409Onyx Curved ProbeSi-Bone Inc.LXH2026-09-29
00810055525416Onyx 8.25mm TrephineSi-Bone Inc.LXH2026-09-29
00810055525423Onyx Threaded Removal DriverSi-Bone Inc.LXH2026-09-29
00810055525430Onyx 5.5 & 6.5mm OsteotomeSi-Bone Inc.LXH2026-09-29
00810055525447Onyx 7.5mm OsteotomeSi-Bone Inc.LXH2026-09-29
00810055525454Onyx Counter Torque, ShortSi-Bone Inc.LXH2026-09-29
00810055525461Onyx Counter TorqueSi-Bone Inc.LXH2026-09-29
00810055525478Onyx Counter Torque, LongSi-Bone Inc.LXH2026-09-29
00810055525485Onyx Head TurnerSi-Bone Inc.LXH2026-09-29