Aju Medical Co., Ltd.

FDA Device Registration & Listing · Seongnam-si Gyeonggi, KR · Registration 3014232239

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014232239
FEI Number
3014232239
Entity Name
Aju Medical Co., Ltd.
City/State/Country
Seongnam-si Gyeonggi, KR
Establishment Address
Room 201, Room 207, BL A, 697, Pangyo-ro, Bundang-gu, Seongnam-si Gyeonggi 13511, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
AJU Medical Co., Ltd. (Owner Number: 10056622)
Owner / Operator Contact Address
Room 201, Room 207, BL A, 697, Pangyo-ro, Bundang-gu, Seongnam-si, KR-41 13511, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Fixone Biocomposite Interference Screw (I type) Genesis Drill Guide Genesis Dual Pitch AWL/Tapper Genesis Drill Bit Awl/Tapper Dual Pitch Awl/Tapper Drill Bit Fixone Instrument Genesis AWL/Tapper Genesis AWL Awl Drill Guide Fixone Hybrid Anchor (KP,KPN type) AlternatiV+ Max Knotless Anchor (KPN type) Genesis Knotless Anchor (KPN type)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-01-20
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2017-12-26
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-08-25

Official Correspondent

No official correspondent registered.

US Agent Details

Peter Chung Email: peterchung210@gmail.com Phone: (412) 5128802

Related Public Records

Same Entity

AJU Medical Co., Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27
K972722 Orthopedic Designs, Inc. ULTIMATE COMPRESSION SCREW SYSTEM 1998-01-23
K192974 Tyber Medical, LLC Tyber Medical Trauma Screw 2020-01-08
K082949 OrthoPediatrics Corp. ORTHOPEDIATRICS BONE SCREWS 2008-11-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014232239. Last updated year: 2026. Please use registration number 3014232239 when referencing this establishment in official correspondence.
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