Arthrex do Brazil Importacao e Comercio de Equipamentos Medicos Ltda

FDA Device Registration & Listing · Sao Paulo, BR · Registration 3015974593

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
3015974593
FEI Number
3015974593
Entity Name
Arthrex do Brazil Importacao e Comercio de Equipamentos Medicos Ltda
City/State/Country
Sao Paulo, BR
Establishment Address
Rua Delegado Moraes Novaes 196 - Vila Andrade, Sao Paulo 05718-310, BR
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
K223759
PMA Number
N/A

All Registered Proprietary Names

Arthrex Low Profile Screws FIBERWIRE BUTTON REPAIR KIT Arthrex Fracture System orthopedic manual instrument handle, scalpel ARTHROSCOPY LEG HOLDER Orthopedic Template Fastener, Fixation, nondegradable, soft tissue Syringe, Irrigating (Non Dental) BIOCOMPOSITE INTERFERENCE SCREW TRIM-IT FAMILY Arthrex PushLock VARIOUS IMPLANTS HUMERAL FRACTURE PLATE Arthrex Fracture System VARIOUS INSTRUMENTS orthopedic manual instrument MENISCAL DART, DARTSTICK, CHONDRAL DART Arthrex SwiveLock Anchors General Hospital and Personal Use Miscellaneous Devices Weight, 2.5 lb (1.1kg) Protector, Skin Pressure fixation pin Arthrex MicroSuture Anchors Instrument, manual, surgical, general use Component, Traction, Non-Invasive Camera Heads SHAVER SYSTEM smooth or threaded metallic bone fixation fastener Fracture Plates & Screws Table Attachments, Operating-Room orthopedic manual instrument SHOULDER HOLDER Apparatus, Traction, Non-Powered Arthrex Low Profile Screws drill bit FASTAK SUTURE ANCHOR WASHER Manual surgical instrument for general use. CONTINUOUS WAVE III Arthrex Plates, Screws, and Staples orthopedic manual instrument BIO-COMPRESSION SCREW orthopedic manual instrument VARIOUS BURS BIO-PIN OSTEOTOMY PLATE ARTHROERESIS IMPLANT Arthroscopes Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories Graft Delivery Device with Integrated Stylet MENISCAL CINCH SHAVER BLADES Arthrex PCL TightRope TENODESIS FAMILY Arthrex Pushlock CORKSCREW ANCHORS Arthrex BioComposite SutureTak PUSHLOCK Instrument, Special Lens, For Endoscope WASHER Orthopedic manual surgical instrument, Passer orthopedic manual instrument OPES ELECTRODES AND ACCESSORIES RF device, blade, hook ANATOEMIC PROSTHESIS ARTHREX ANATOEMIC P

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-01-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-01-19
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2008-11-26
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-09-12
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
HXB Probe Orthopedic Class 1 888.4540 2003-08-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-04-17
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2019-04-17
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-12-01
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2021-09-10
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2007-08-23
HWT Template Orthopedic Class 1 888.4800 2014-08-21
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-08-20
KYZ Syringe, Irrigating (Non Dental) General Hospital Class 1 880.6960 2022-06-09
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
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
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
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
OSV Insufflator, Endoscopic Vessel Harvesting Obstetrics/Gynecology Class 2 884.1730 2023-08-03
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2023-08-03
FCX Insufflator, Automatic Carbon-Dioxide For Endoscope Gastroenterology, Urology Class 2 876.1500 2023-08-03
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2018-03-28
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
FMF Syringe, Piston General Hospital Class 2 880.5860 2012-09-04
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2019-11-27
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 2013-07-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-07-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-01-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-01-19
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2007-08-23
HXJ Staple Driver Orthopedic Class 1 888.4540 2008-11-26
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-03-13
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-09-24
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2009-04-16
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2009-04-16
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
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2021-08-30
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2007-08-23
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
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2007-08-23
KQZ Component, Traction, Non-Invasive Orthopedic Class 1 888.5890 1996-08-07
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2017-01-25
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 2015-06-23
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
BWN Table And Attachments, Operating-Room General, Plastic Surgery Class 1 878.4950 2018-07-03
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2001-07-13
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-08-11
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2007-08-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-04-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2011-04-06
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 2013-03-08
HTW Bit, Drill Orthopedic Class 1 888.4540 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
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 2008-11-26
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2007-08-23
GES Blade, Scalpel General, Plastic Surgery Class 1 878.4800 2022-02-23
HRX Arthroscope Orthopedic Class 2 888.1100 2008-07-31
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
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2017-09-28
HTD Forceps General, Plastic Surgery Class 1 878.4800 2003-08-07
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
HTO Reamer Orthopedic Class 1 888.4540 1994-01-27
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2007-08-23
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2020-07-27
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2007-08-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2008-11-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2008-11-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
LXI Guide, Drill, Ligament General, Plastic Surgery Class 1 878.4820 2018-02-27
HRX Arthroscope Orthopedic Class 2 888.1100 2012-12-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-08-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-08-25
FMF Syringe, Piston General Hospital Class 2 880.5860 2022-06-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-01-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2021-01-05
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
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2007-08-23
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
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
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-04-14
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 2011-01-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2011-01-31
HRX Arthroscope Orthopedic Class 2 888.1100 2021-12-20
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2020-04-09
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
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
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
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
FEI Instrument, Special Lens, For Endoscope Gastroenterology, Urology Class 1 876.1500 2017-01-25
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2007-08-23
HWQ Passer Orthopedic Class 1 888.4540 2003-08-07
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2003-08-07
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-07-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2020-07-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2016-04-13
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-11-26
KWD Prosthesis, Toe, Hemi-, Phalangeal Orthopedic Class 2 888.3730 2007-01-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-06-02
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

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
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
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

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 3015974593. Last updated year: 2026. Please use registration number 3015974593 when referencing this establishment in official correspondence.
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