Arthrex Mexico, S.A. de C.V.

FDA Device Registration & Listing · Col. Napoles Mexico, MX · Registration 3011230048

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
3011230048
FEI Number
3011230048
Entity Name
Arthrex Mexico, S.A. de C.V.
City/State/Country
Col. Napoles Mexico, MX
Establishment Address
Insurgentes Sur No. 859, Oficina 101, Col. Napoles Mexico 03810, MX
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
K021434
PMA Number
N/A

All Registered Proprietary Names

Bio-Composite SutureTak ARTHROERESIS IMPLANT Arthroscopes VARIOUS IMPLANTS SHAVER SYSTEM single/ multiple component metallic bone fixation appliances and accessories Arthrex Mini TightRopes ARTHROSCOPY LEG HOLDER Arthrex Low Profile Screws Arthrex BioComposite SutureTak Arthrex Fracture System fixation plate LOW PROFILE PLATE AND SCREW SYSTEM INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT OPES ELECTRODES AND ACCESSORIES RF device, blade, hook TENODESIS FAMILY Arthrex Tibial GraftBolt BIO-CORKSCREW FT General Hospital and Personal Use Miscellaneous Devices Weight, 2.5 lb (1.1kg) Protector, Skin Pressure Mini TightRope CMC Clamp MENISCAL CINCH Arthrex Tibial GraftBolt Laproscopes Arthrex Fracture Plates VARIOUS BURS Camera Heads SHOULDER HOLDER Apparatus, Traction, Non-Powered BIO-PIN smooth or threaded metallic bone fixation fastener Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories drill bit Arthrex Low Profile Screws Arthrex SwiveLock Anchors PUSHLOCK FASTAK SUTURE ANCHOR WASHER RETROBUTTON Instrument, manual, surgical, general use ORTHOPEDIC MANUAL INSTRUMENTS BIO-ABSORBABLE CORKSCREW BIOCOMPOSITE INTERFERENCE SCREW Fracture Plates & Screws BIOCOMPOSITE SUTURE ANCHORS Dual Wave Pump Table Attachments, Operating-Room FiberTape Fiberstick FiberWire

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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 2007-08-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-11-20
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2025-01-23
HRX Arthroscope Orthopedic Class 2 888.1100 2012-12-28
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
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2008-11-26
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-03-12
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2014-03-21
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2017-01-24
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2007-08-23
HRX Arthroscope Orthopedic Class 2 888.1100 2021-12-20
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-09-24
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2021-07-23
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2021-07-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-07-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-07-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-02-13
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2024-05-30
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2016-04-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-11-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-11-18
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 2011-04-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-04-06
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
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-26
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2016-04-13
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 1996-08-07
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 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
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2010-04-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
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
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2021-08-30
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 2015-04-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-04-06
HXD Clamp General, Plastic Surgery Class 1 878.4800 2023-05-24
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-03-08
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-09-12
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
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
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2011-05-27
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2012-12-28
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
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 2013-04-11
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-04-11
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 2017-09-28
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
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2017-01-25
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-04-14
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2007-08-23
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2007-08-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2015-06-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-08-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-08-25
HTW Bit, Drill Orthopedic Class 1 888.4540 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
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-01-11
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2011-01-11
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2022-09-12
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
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2008-11-26
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2007-08-23
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
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2007-08-23
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2007-08-23
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
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2017-05-30
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
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 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
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 2009-04-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2009-04-16
HRX Arthroscope Orthopedic Class 2 888.1100 2009-08-27
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 2007-11-28

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 3011230048. Last updated year: 2026. Please use registration number 3011230048 when referencing this establishment in official correspondence.
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