FDA.reportPublic FDA data

HKT Anatomical Lciking Trauma System

Primary DI
8809596471902
Brand
HKT Anatomical Lciking Trauma System
Company
Hankil Tech Medical Co., Ltd.
Model
12203-35034
Catalog number
12203-35034
Published
2024-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809596471902PrimaryGS10
8809596471902Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809596471902088095964719028809596471902

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length34Millimeter

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
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569658212Xpert PFPNEWCLIP TECHNICSHWC2026-06-03
00370056966385Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
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
03700569658151Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658175Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658199Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569662202Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663247Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663841Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663865Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663872Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663889Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663896Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663902Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663919Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663926Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663933Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663940Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663964Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569671327Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676438Xpert PFPNEWCLIP TECHNICSHRS2026-06-02