FDA.reportPublic FDA data

HKT Anatomical Locking Trauma System

Primary DI
08809596471858
Brand
HKT Anatomical Locking Trauma System
Company
Hankil Tech Medical Co., Ltd.
Model
12203-35024
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
08809596471858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809596471858088095964718588809596471858

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
Length24Millimeter

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
08809596471872HKT Anatomical Locking Trauma System12203-3502812203-350282025-03-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569658212Xpert PFPNEWCLIP TECHNICSHWC2026-06-03
00842188131981CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132056CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132063Tools - HCSTrimed, INC.HWC2026-06-02
00842188132070Tools - HCSTrimed, INC.HWC2026-06-02
07630894829819APTUSMedartis AGHWC2026-06-01
07630894829826APTUSMedartis AGHWC2026-06-01
07630894829833APTUSMedartis AGHWC2026-06-01
07630894829840APTUSMedartis AGHWC2026-06-01
07630894829857APTUSMedartis AGHWC2026-06-01
07630894829864APTUSMedartis AGHWC2026-06-01
07630894829871APTUSMedartis AGHWC2026-06-01
07630894829888APTUSMedartis AGHWC2026-06-01
07630894829895APTUSMedartis AGHWC2026-06-01
07630894829901APTUSMedartis AGHWC2026-06-01
07630894829918APTUSMedartis AGHWC2026-06-01
07630894829925APTUSMedartis AGHWC2026-06-01
07630894829932APTUSMedartis AGHWC2026-06-01
07630894829949APTUSMedartis AGHWC2026-06-01
07630894829956APTUSMedartis AGHWC2026-06-01
07630894829963APTUSMedartis AGHWC2026-06-01
07630894829970APTUSMedartis AGHWC2026-06-01
07630894829987APTUSMedartis AGHWC2026-06-01
07630894829994APTUSMedartis AGHWC2026-06-01