FDA.reportPublic FDA data

HKT Anatomical Locking Trauma System

Primary DI
08809407600583
Brand
HKT Anatomical Locking Trauma System
Company
Hankil Tech Medical Co., Ltd.
Model
11424-92015
Catalog number
11424-92015
Published
2024-05-10
Public version status
Update
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
HRSPlate, Fixation, Bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809407600583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809407600583088094076005838809407600583

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
Height15Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+821087060335yh_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
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
8809596471902HKT Anatomical Lciking Trauma System12203-3503412203-350342024-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
03700569676445Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676452Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676469Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
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00850080543016PC Fix Locking Cap TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543023PC Fix Washer TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543030PC Fix Extrathoracic Plate 70mm TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543047PC Fix Extrathoracic Plate 95mm TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543054PC Fix Intrathoracic Plate 70mm TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543061PC Fix Intrathoracic Plate 95mm TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543078PC Fix Thoracic Plate 70mm PEEKChest Wall Innovations, Inc.HRS2026-06-01