FDA Registration Active 🇧🇷 Brazil

Arthrex do Brazil Importacao e Comercio de Equipamentos Medicos Ltda

Reg #: 3015974593 · FEI: 3015974593 · Expires 2026
Products
51
Proprietary Names
76
Establishment Types
1
Classifications
51

Registration Details

Registration Name
Arthrex do Brazil Importacao e Comercio de Equipamentos Medicos Ltda
Registration Number
3015974593
FEI Number
3015974593
Status
Active
Expiry Year
2026
Initial Importer
No
Address
Rua Delegado Moraes Novaes 196 - Vila Andrade
City
Sao Paulo
Country
BR

Regulatory Submissions

510(k) Number
K143614

Owner / Operator

Firm Name
ARTHREX, INC.
Operator Number
1220287
Address
1370 CREEKSIDE BLVD., --
City
Naples
State
FL
Postal Code
34108
Country
US
Correspondent
Barry Dietz

US Agent

Business Name
Arthrex Inc
Contact Name
Barry Dietz
Address
1370 Creekside Blvd
City
Naples
State
FL
ZIP
34108
Country
US
Phone
800 9337001

Products

Device Name Product Code
Plate, Fixation, Bone HRS
Screw, Fixation, Bone HWC
Suture, Nonabsorbable, Synthetic, Polyethylene GAT
Electrosurgical, Cutting & Coagulation & Accessories GEI
Washer, Bolt Nut HTN
Probe HXB
Fastener, Fixation, Nondegradable, Soft Tissue MBI
Handle, Scalpel GDZ
Operating Room Accessories Table Tray FWZ
Template HWT
Syringe, Irrigating (Non Dental) KYZ
Fastener, Fixation, Biodegradable, Soft Tissue MAI
Pin, Fixation, Smooth HTY
Cerclage, Fixation JDQ
Insufflator, Endoscopic Vessel Harvesting OSV
Insufflator, Laparoscopic HIF
Insufflator, Automatic Carbon-Dioxide For Endoscope FCX
Syringe, Piston FMF
Accessories, Arthroscopic NBH
Staple Driver HXJ
Staple, Fixation, Bone JDR
Protector, Skin Pressure FMP
Instrument, Manual, Surgical, General Use MDM
Component, Traction, Non-Invasive KQZ
Camera, Surgical And Accessories KQM
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Table And Attachments, Operating-Room BWN
Gauge, Depth HTJ
Apparatus, Traction, Non-Powered HST
Bit, Drill HTW
System, X-Ray, Angiographic IZI
Laparoscope, General & Plastic Surgery GCJ
Blade, Scalpel GES
Arthroscope HRX
Forceps HTD
Reamer HTO
Bur, Surgical, General & Plastic Surgery GFF
Guide, Drill, Ligament LXI
Blade, Saw, General & Plastic Surgery, Surgical GFA
Medical Device Data System OUG
Platelet And Plasma Separator For Bone Graft Handling ORG
Instrument, Special Lens, For Endoscope FEI
Passer HWQ
Punch, Surgical LRY
Prosthesis, Toe, Hemi-, Phalangeal KWD
Instrument, Biopsy KNW
Suture, Nonabsorbable, Silk GAP
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use JQC
Orthopedic Manual Surgical Instrument LXH
Tubing, Noninvasive GAZ
Drape, Surgical, Exempt PUI

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 VARIOUS INSTRUMENTS 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 SHOULDER HOLDER Apparatus, Traction, Non-Powered drill bit FASTAK SUTURE ANCHOR WASHER Manual surgical instrument for general use. CONTINUOUS WAVE III Arthrex Plates, Screws, and Staples BIO-COMPRESSION SCREW 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 Orthopedic manual surgical instrument, Passer OPES ELECTRODES AND ACCESSORIES RF device, blade, hook ANATOEMIC PROSTHESIS ARTHREX ANATOEMIC P INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT RETROBUTTON fixation plate Arthrex Suture Dual Wave Pump Laproscopes ORTHOPEDIC MANUAL INSTRUMENTS single/ multiple component metallic bone fixation appliances and accessories Arthrex Mini TightRopes LOW PROFILE PLATE AND SCREW SYSTEM BIOCOMPOSITE SUTURE ANCHORS Arthrex Fracture Plates Drape, Surgical, Exempt BIO-CORKSCREW FT INTERFERENCE SCREWS

Establishment Types

Export Device to the United States But Perform No Other Operation on Device