FDA.reportPublic FDA data

Smooth Pin - 3.2mm x 70mm – x5

Primary DI
09421038410660
Brand
Smooth Pin - 3.2mm x 70mm – x5
Company
ENZTEC LIMITED
Model
5000-2001-5
Catalog number
5000-2001-5
Device description
A single use surgical instrument intended to be used during an orthopaedic surgical procedure
Published
2025-10-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
09421038410660PrimaryGS10
09421038410783Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421038410660094210384106609421038410660
09421038410783094210384107839421038410783

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic intraoperative positioning pin, single-useA nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
592616445
Device count
5
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421038413159Reamer, Acetabular, 36mm Full5900-RF365900-RF362026-04-16
09421038413166Reamer, Acetabular, 37mm Full5900-RF375900-RF372026-04-16
09421038413173Reamer, Acetabular, 38mm Full5900-RF385900-RF382026-04-16
09421038413180Reamer, Acetabular, 39mm Full5900-RF395900-RF392026-04-16
09421038413197Reamer, Acetabular, 40mm Full5900-RF405900-RF402026-04-16
09421038413203Reamer, Acetabular, 41mm Full5900-RF415900-RF412026-04-16
09421038413210Reamer, Acetabular, 42mm Full5900-RF425900-RF422026-04-16
09421038413227Reamer, Acetabular, 43mm Full5900-RF435900-RF432026-04-16
09421038413234Reamer, Acetabular, 44mm Full5900-RF445900-RF442026-04-16
09421038413241Reamer, Acetabular, 45mm Full5900-RF455900-RF452026-04-16
09421038413258Reamer, Acetabular, 46mm Full5900-RF465900-RF462026-04-16
09421038413265Reamer, Acetabular, 47mm Full5900-RF475900-RF472026-04-16
09421038413272Reamer, Acetabular, 48mm Full5900-RF485900-RF482026-04-16
09421038413289Reamer, Acetabular, 49mm Full5900-RF495900-RF492026-04-16
09421038413296Reamer, Acetabular, 50mm Full5900-RF505900-RF502026-04-16
09421038413302Reamer, Acetabular, 51mm Full5900-RF515900-RF512026-04-16
09421038413319Reamer, Acetabular, 52mm Full5900-RF525900-RF522026-04-16
09421038413326Reamer, Acetabular, 53mm Full5900-RF535900-RF532026-04-16
09421038413333Reamer, Acetabular, 54mm Full5900-RF545900-RF542026-04-16
09421038413340Reamer, Acetabular, 55mm Full5900-RF555900-RF552026-04-16

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