FDA.reportPublic FDA data

HKT Anatomical Locking Trauma System

Primary DI
08809596471872
Brand
HKT Anatomical Locking Trauma System
Company
Hankil Tech Medical Co., Ltd.
Model
12203-35028
Catalog number
12203-35028
Published
2025-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809596471872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809596471872088095964718728809596471872

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length28Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+821090544233yh_park@ostymeditech.com

Regulatory Flags#

DUNS number
688499031
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809407600569Ball Tip Probe18-1622025-12-16
08809407604543Dissector48-0052025-12-16
08809596471704Endo Curette09-2712025-12-16
08809596474019Kerrison Rotating Rongeur Shaft21-4492025-12-16
08809596474071Endo Scope Kerrision Rotating Rongeur Shaft21-4622025-12-16
08809596474095Endo Scope Kerrision Rotating Rongeur Shaft21-4642025-12-16
08809596474996Kerrison Rotating Rongeur Handle21-4002025-12-16
08809407600590HKT Anatomical Lciking Trauma System11424-9202011424-920202024-08-13
08809407600606HKT Anatomical Lciking Trauma System11424-9203511424-920352024-08-13
08809407600644HKT Anatomical Lciking Trauma System11424-9204011424-920402024-08-13
08809407600699HKT Anatomical Lciking Trauma System11424-9205011424-920502024-08-13
08809946780432HKT Anatomical Lciking Trauma System16104-0100416104-010042024-08-13
08809407600583HKT Anatomical Locking Trauma System11424-9201511424-920152024-05-10
08809596471858HKT Anatomical Locking Trauma System12203-350242025-03-05
08809596471889HKT Anatomical Lciking Trauma System12203-3503012203-350302024-08-13
08809596471902HKT Anatomical Lciking Trauma System12203-3503412203-350342024-08-13
0880945251920516205-01050; 16205-01110; 60-02516205-0111016205-011102024-08-13
0880959542126716206-01050; 60-041; 60-04260-04160-0412024-08-13
8809596471889HKT Anatomical Lciking Trauma System12203-3503012203-350302024-08-13
8809596471902HKT Anatomical Lciking Trauma System12203-3503412203-350342024-08-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00885556904879EVOSSmith & Nephew, Inc.HWC2026-06-25
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00885556906187EVOSSmith & Nephew, Inc.HWC2026-06-25
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00193982586393CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
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