Arthrex Korea Ltd.

FDA Device Registration & Listing · Gangnam-gu Seoul, KR · Registration 3013700547

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
3013700547
FEI Number
3013700547
Entity Name
Arthrex Korea Ltd.
City/State/Country
Gangnam-gu Seoul, KR
Establishment Address
Parnas Tower, 20th Floor, 521 Teheran-ro, Gangnam-gu Seoul 06164, KR
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
ARTHREX, INC. (Owner Number: 1220287)
Owner / Operator Contact Address
1370 CREEKSIDE BLVD., --, Naples, FL 34108, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K140855
PMA Number
N/A

All Registered Proprietary Names

iBalance Orthopedic Template orthopedic manual instrument OSTEOTOMY PLATE SHOULDER HOLDER Apparatus, Traction, Non-Powered PUSHLOCK COMPRESSION STAPLE Dual Wave Pump Arthrex Plates, Screws, and Staples Camera Heads drill bit BIO-PIN Arthrex Low Profile Screws FASTAK SUTURE ANCHOR CORKSCREW ANCHORS Arthrex Distal Extremity Plate System SHAVER SYSTEM WASHER Arthrex Low Profile Screws Arthrex Tibial GraftBolt TAK FAMILY HUMERAL FRACTURE PLATE orthopedic manual instrument Table Attachments, Operating-Room Arthrex PCL TightRope Arthrex Suture OPES ELECTRODES AND ACCESSORIES RF device, blade, hook RETROBUTTON orthopedic manual instrument Instrument, manual, surgical, general use ARTHROERESIS IMPLANT Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories BIO-ABSORBABLE CORKSCREW Component, Traction, Non-Invasive orthopedic manual instrument VARIOUS BURS smooth or threaded metallic bone fixation fastener Arthroscopes Arthrex Fracture System CONTINUOUS WAVE III BIOCOMPOSITE SUTURE ANCHORS Arthrex Fracture System Arthrex Pushlock UNIVERS II BIO-CORKSCREW FT SHAVER BLADES Laproscopes CAMERA, CINE, ENDOSCOPIC, WITHOUT AUDIO INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT BIO-COMPRESSION SCREW fixation plate LOW PROFILE PLATE AND SCREW SYSTEM TENODESIS FAMILY DOUBLE SYRINGE (ACP) SYSTEM Bio-Composite SutureTak ORTHOPEDIC MANUAL INSTRUMENTS Fracture Plates & Screws

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2010-03-29
HWT Template Orthopedic Class 1 888.4800 2014-08-21
HTZ Instrument, Cutting, Orthopedic General, Plastic Surgery Class 1 878.4800 1996-08-07
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-03-06
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2020-03-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-26
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2007-08-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2007-08-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2007-08-23
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
HRX Arthroscope Orthopedic Class 2 888.1100 2009-08-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-07-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-07-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-11-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-11-18
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2015-07-17
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-07-17
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-07-17
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2018-06-26
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-06-26
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-11-20
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2008-11-26
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2017-01-25
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2018-03-05
HTW Bit, Drill Orthopedic Class 1 888.4540 2007-08-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2016-04-13
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2007-08-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-01-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-01-19
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2008-11-26
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2007-08-23
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2007-08-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2007-08-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2011-08-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-08-26
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2008-11-26
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2007-08-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-01-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-01-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-04-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2011-04-06
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-04-24
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2023-04-24
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2010-04-13
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-03-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2007-08-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2007-08-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-02-10
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-02-10
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2015-07-17
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-04-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
HTO Reamer Orthopedic Class 1 888.4540 1994-01-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-06-02
BWN Table And Attachments, Operating-Room General, Plastic Surgery Class 1 878.4950 2018-07-03
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2011-05-31
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2011-05-31
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2013-12-31
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2012-10-11
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-09-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-11-26
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2008-11-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2008-11-26
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2001-07-13
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2007-08-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-08-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-08-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-26
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2008-11-26
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2008-11-26
KQZ Component, Traction, Non-Invasive Orthopedic Class 1 888.5890 1996-08-07
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-07-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-07-28
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2003-08-07
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2007-08-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2015-06-23
HRX Arthroscope Orthopedic Class 2 888.1100 2012-12-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-01-16
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2012-01-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-01-16
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-03-08
HRX Arthroscope Orthopedic Class 2 888.1100 2008-07-31
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2017-09-28
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2009-04-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2009-04-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-01-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-01-19
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2011-01-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-01-31
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2008-11-26
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2008-11-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2007-08-23
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2012-12-28
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2012-05-15
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2012-05-15
FWL Camera, Cine, Endoscopic, Without Audio General, Plastic Surgery Class 1 878.4160 1994-01-27
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 1996-08-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2007-08-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2007-08-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
FMF Syringe, Piston General Hospital Class 2 880.5860 2009-04-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2009-09-08
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2009-09-08
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2007-08-23
OUG Medical Device Data System General Hospital Class 1 880.6310 2017-12-13
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2015-01-12
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2015-01-12

Official Correspondent

Barry Dietz

US Agent Details

Barry Dietz Business: Arthrex Inc Email: Regulatory_Affairs@Arthrex.com Phone: (800) 9337001

Related Public Records

Same Entity

ARTHREX, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3031238646 Arthrex Medical Device (Shanghai) Co. Ltd. Shanghai, CN
3007193505 ARTHREX GMBH Odelzhausen Bavaria, DE
3014004349 Arthrex Singapore Pte Ltd. Singapore Central Singapore, SG
3020704423 Arthrex New Zealand Limited Auckland, NZ
3011230048 Arthrex Mexico, S.A. de C.V. Col. Napoles Mexico, MX

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29
K190842 Jiangsu Trauhui Medical Instrument Co., Ltd. Comus Locking Plate systems 2020-02-03
K130510 Arthrex, Inc. ARTHREX COMPRESSION PLATES 2013-09-25
K202803 Newclip Technics Activmotion S DTO 2021-12-16
K193295 Parcus Medical, LLC Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor 2020-01-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013700547. Last updated year: 2026. Please use registration number 3013700547 when referencing this establishment in official correspondence.
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