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
- [email protected]
- Phone
- 800 9337001
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2015-01-19 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2015-01-19 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2008-11-26 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2016-09-12 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2012-01-16 |
| Probe | HXB | Class 1 | Orthopedic | No | 2003-08-07 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2019-04-17 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2021-09-10 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2007-08-23 |
| Template | HWT | Class 1 | Orthopedic | No | 2014-08-21 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2022-06-09 |
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2008-11-26 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2012-05-15 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2023-10-09 |
| Insufflator, Endoscopic Vessel Harvesting | OSV | Class 2 | Obstetrics/Gynecology | No | 2023-08-03 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2023-08-03 |
| Insufflator, Automatic Carbon-Dioxide For Endoscope | FCX | Class 2 | Gastroenterology, Urology | No | 2023-08-03 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2012-09-04 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2007-08-23 |
| Staple Driver | HXJ | Class 1 | Orthopedic | No | 2008-11-26 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2008-11-26 |
| Protector, Skin Pressure | FMP | Class 1 | General Hospital | No | 2021-08-30 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2007-08-23 |
| Component, Traction, Non-Invasive | KQZ | Class 1 | Orthopedic | No | 1996-08-07 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2017-01-25 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2008-11-26 |
| Table And Attachments, Operating-Room | BWN | Class 1 | General, Plastic Surgery | No | 2018-07-03 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2001-07-13 |
| Apparatus, Traction, Non-Powered | HST | Class 1 | Orthopedic | No | 2007-08-23 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2007-08-23 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2024-07-26 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2024-07-26 |
| Blade, Scalpel | GES | Class 1 | General, Plastic Surgery | No | 2022-02-23 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2008-07-31 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2003-08-07 |
| Reamer | HTO | Class 1 | Orthopedic | No | 1994-01-27 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2007-08-23 |
| Guide, Drill, Ligament | LXI | Class 1 | General, Plastic Surgery | No | 2018-02-27 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2007-08-23 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2017-12-13 |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | Class 2 | Hematology | No | 2020-04-09 |
| Instrument, Special Lens, For Endoscope | FEI | Class 1 | Gastroenterology, Urology | No | 2017-01-25 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2003-08-07 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2003-08-07 |
| Prosthesis, Toe, Hemi-, Phalangeal | KWD | Class 2 | Orthopedic | No | 2007-01-31 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2021-11-19 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2008-11-26 |
| Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | JQC | Class 1 | Clinical Chemistry | No | 2017-01-24 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2007-08-23 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2020-12-17 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2024-03-28 |
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