FDA.reportPublic FDA data

HKT Anatomical Lciking Trauma System

Primary DI
08809946780418
Brand
HKT Anatomical Lciking Trauma System
Company
Hankil Tech Medical Co., Ltd.
Model
16203-03031
Catalog number
16203-03031
Device description
3.0mm Variable Drill Guide (w/o Grip)
Published
2024-08-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809946780418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809946780418088099467804188809946780418

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3Millimeter

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
Premarket exempt
true
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
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

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Primary DI, Brand, Company table
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00889024707405Persona Tensor Sizer BodyZimmer, Inc.FZX2026-05-29
G079INL1160070Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
G079INL1160120Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
08806373887772BENCOX Surgical InstrumentsCorentec Co., LtdFZX2026-01-12
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G463090799PK0Spine InstrumentsBOXSPINE HOLDINGS, INC.FZX2025-01-16
008101182101673.7mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
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008101182101815.5mm Parallel PinOsteocentric Technologies, Inc.FZX2023-10-30
08800089436033Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17