Arthrex (Shanghai) Co., Ltd.

FDA Device Registration & Listing · Shanghai, CN · Registration 3014262693

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
3014262693
FEI Number
3014262693
Entity Name
Arthrex (Shanghai) Co., Ltd.
City/State/Country
Shanghai, CN
Establishment Address
2205-2208 Garden Square, 968 Beijing West Road, Shanghai 200041, CN
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
K101837
PMA Number
N/A

All Registered Proprietary Names

Arthrex Low Profile Screws FiberTape Fiberstick FiberWire orthopedic manual instrument Bio-Composite SutureTak INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT SHOULDER HOLDER Apparatus, Traction, Non-Powered smooth or threaded metallic bone fixation fastener CONTINUOUS WAVE III Dual Wave Pump TENODESIS FAMILY TAK FAMILY Camera, Television, Surgical, Without Audio Arthroscopes ORTHOPEDIC MANUAL INSTRUMENTS Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex Orthovis Preoperative Plan, Smartbase For Arthrex Glenoi COMPRESSION STAPLE single/ multiple component metallic bone fixation appliances and accessories Arthrex Mini TightRopes Arthrex PCL TightRope Mini TightRope CMC fixation pin Arthrex Tibial GraftBolt PUSHLOCK CORKSCREW ANCHORS Instrument, Special Lens, For Endoscope Arthrex MicroSuture Anchors DOUBLE SYRINGE (ACP) SYSTEM fixation plate LOW PROFILE PLATE AND SCREW SYSTEM OSTEOTOMY PLATE Arthrex Low Profile Screws Arthrex Biocomposite Transfix Orthopedic Template Arthrex Plates, Screws, and Staples Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories INTERFERENCE SCREWS ACL TightRope orthopedic manual instrument BIOCOMPOSITE SUTURE ANCHORS Arthrex BioComposite SutureTak Arthrex Pushlock MENISCAL CINCH Single/multiple component metallic bone fixation appliances and accessories Arthrex Ankle Fusion Plating System VARIOUS INSTRUMENTS drill bit Shoulder joint metal/ polymer semi-constrained cemented prosthesis Univers Revers Shoulder Prosthesis System Fracture Plates & Screws VARIOUS IMPLANTS ACL TightRope Double Bundle

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-04-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2011-04-06
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2007-11-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-05-30
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2003-08-07
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Orthopedic Class 2 888.3660 2020-07-09
QHQ Total Shoulder Arthroplasty System Orthopedic Class 2 888.3660 2020-07-09
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
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-05-17
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-05-17
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-05-17
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2020-11-04
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-11-04
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-09-24
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2019-12-18
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2019-12-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-07-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-07-16
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2017-09-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-11-20
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 1996-08-07
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2007-08-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2015-06-23
HRX Arthroscope Orthopedic Class 2 888.1100 2008-07-31
HRX Arthroscope Orthopedic Class 2 888.1100 2009-08-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-01-03
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-08-11
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
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
FWB Camera, Television, Surgical, Without Audio General, Plastic Surgery Class 1 878.4160 2024-07-25
HRX Arthroscope Orthopedic Class 2 888.1100 2012-12-28
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2020-04-09
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2007-08-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-12-05
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-06-02
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-01-22
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2024-01-22
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2018-05-18
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2018-05-18
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2018-05-18
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2015-07-17
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2022-09-26
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2016-04-27
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2016-04-27
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
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2024-07-26
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-07-26
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-09-12
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2014-03-21
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
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2009-12-07
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2009-12-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-10-09
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2023-10-09
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2023-10-09
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2023-10-09
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2007-08-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2010-04-13
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
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
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
FEI Instrument, Special Lens, For Endoscope Gastroenterology, Urology Class 1 876.1500 2017-01-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-09-14
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2011-09-14
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2011-09-14
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-04-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-08-23
JDQ Cerclage, Fixation Orthopedic Class 2 888.3010 2022-08-23
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2022-08-23
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-08-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2016-06-14
LXI Guide, Drill, Ligament General, Plastic Surgery Class 1 878.4820 2018-02-27
FMF Syringe, Piston General Hospital Class 2 880.5860 2009-04-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-26
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 2012-01-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-01-24
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2008-11-26
HWT Template Orthopedic Class 1 888.4800 2014-08-21
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-01-23
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
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 2007-08-23
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
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-08-23
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 2010-06-23
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2010-06-23
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2001-07-13
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
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2011-04-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-04-06
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-04-14
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-03-12
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
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2008-11-26
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2008-11-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-05-22
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2018-05-22
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2016-06-14
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2016-06-14
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2016-09-01
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-03-08
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2014-08-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-08-20
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-08-20
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2007-08-23
HTW Bit, Drill Orthopedic Class 1 888.4540 2007-08-23
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2015-02-09
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
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-12-01
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2020-12-01
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
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2008-11-26
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-08-06
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2013-08-06
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2021-04-19
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2021-04-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-07-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-07-28
GAP Suture, Nonabsorbable, Silk General, Plastic Surgery Class 2 878.5030 2011-01-17
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2011-01-17
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2011-01-17

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
3013700547 Arthrex Korea Ltd. Gangnam-gu Seoul, KR
3014004349 Arthrex Singapore Pte Ltd. Singapore Central Singapore, SG
3020704423 Arthrex New Zealand Limited Auckland, NZ

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 3014262693. Last updated year: 2026. Please use registration number 3014262693 when referencing this establishment in official correspondence.
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