Arthrex Colombia SAS

FDA Device Registration & Listing · Bogota Cundinamarca, CO · Registration 3021226419

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
3021226419
FEI Number
3021226419
Entity Name
Arthrex Colombia SAS
City/State/Country
Bogota Cundinamarca, CO
Establishment Address
Carrera 11 No. 79-35 Piso 9, Bogota Cundinamarca 110221, CO
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
K051726
PMA Number
N/A

All Registered Proprietary Names

FiberTape Fiberstick FiberWire CONTINUOUS WAVE III single/ multiple component metallic bone fixation appliances and accessories Arthrex Mini TightRopes Arthrex Low Profile Screws SHAVER BLADES Laproscopes Arthrex Fracture Plates and Screws Single/multiple component metallic bone fixation appliances and accessories MINI BIO-ANCHOR ACL TightRope ARTHROSCOPY LEG HOLDER Arthroscopes Dual Wave Pump WASHER EXTERNAL FIXATOR SYSTEM orthopedic manual instrument ORTHOPEDIC MANUAL INSTRUMENTS orthopedic manual instrument Camera, Television, Surgical, Without Audio ARTHROERESIS IMPLANT Component, Traction, Non-Invasive General Hospital and Personal Use Miscellaneous Devices Weight, 2.5 lb (1.1kg) Protector, Skin Pressure RETROBUTTON WASHER OPES ELECTRODES AND ACCESSORIES RF device, blade, hook orthopedic manual instrument Syringe, piston 40 L HIGH FLOW INSUFFLATOR F108 VARIOUS BURS ARTHROSCOPY PUMP SHOULDER HOLDER Apparatus, Traction, Non-Powered MENISCAL CINCH Arthrex Pushlock INTERFERENCE SCREWS Instrument, manual, surgical, general use Insufflator 50L FM134 PROSTOP PLUS FIBERWIRE BUTTON REPAIR KIT smooth or threaded metallic bone fixation fastener Fastener, Fixation, nondegradable, soft tissue Orthopedic Template orthopedic manual instrument INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT drill bit Balance, Analytical Mini TightRope CMC TENODESIS FAMILY

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GAT Suture, Nonabsorbable, Synthetic, Polyethylene General, Plastic Surgery Class 2 878.5000 2007-11-28
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
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-03-12
FST Light, Surgical, Fiberoptic General, Plastic Surgery Class 2 878.4580 2021-09-13
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2022-09-26
HRX Arthroscope Orthopedic Class 2 888.1100 2008-07-31
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2014-03-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2015-01-19
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-01-19
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-09-13
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-09-13
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-09-13
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
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2020-09-08
HRX Arthroscope Orthopedic Class 2 888.1100 2020-09-08
GFA Blade, Saw, General & Plastic Surgery, Surgical General, Plastic Surgery Class 1 878.4820 2007-08-23
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2012-12-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2016-04-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-08-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2014-08-25
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2014-08-25
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2017-01-24
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2020-08-25
MAI Fastener, Fixation, Biodegradable, Soft Tissue 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 2015-11-18
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2015-11-18
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
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2007-08-23
HRX Arthroscope Orthopedic Class 2 888.1100 2012-12-28
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2018-09-24
HRX Arthroscope Orthopedic Class 2 888.1100 2009-08-27
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-11-20
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2007-08-23
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2016-04-14
NDK System, External Fixator (With Metallic Invasive Components) Orthopedic Class 2 888.3040 2021-12-20
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
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
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
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2007-08-23
HTO Reamer Orthopedic Class 1 888.4540 1994-01-27
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2019-11-06
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-11-06
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2019-11-06
FWB Camera, Television, Surgical, Without Audio General, Plastic Surgery Class 1 878.4160 2024-07-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2007-08-23
OUG Medical Device Data System General Hospital Class 1 880.6310 2017-12-13
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2021-09-13
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2021-09-13
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2021-09-13
KQZ Component, Traction, Non-Invasive Orthopedic Class 1 888.5890 1996-08-07
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2020-12-01
FMP Protector, Skin Pressure General Hospital Class 1 880.6450 2021-08-30
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 2023-05-19
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
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-09-12
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2007-08-23
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2008-11-26
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2023-08-09
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-03-08
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2001-07-13
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2024-04-26
FMF Syringe, Piston General Hospital Class 2 880.5860 2007-08-23
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2013-12-23
GFF Bur, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4820 2007-08-23
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2013-12-31
HRX Arthroscope Orthopedic Class 2 888.1100 2008-11-26
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2007-08-23
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
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
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
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2007-08-23
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2022-10-18
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2022-10-18
OSV Insufflator, Endoscopic Vessel Harvesting Obstetrics/Gynecology Class 2 884.1730 2021-09-13
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2021-09-13
MAI Fastener, Fixation, Biodegradable, Soft Tissue Orthopedic Class 2 888.3030 2008-11-26
HWC Screw, Fixation, Bone 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
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
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2015-06-23
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-08-20
HWT Template Orthopedic Class 1 888.4800 2014-08-21
LRY Punch, Surgical General, Plastic Surgery Class 1 878.4800 2003-08-07
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 1996-08-07
HTW Bit, Drill Orthopedic Class 1 888.4540 2007-08-23
JQO Balance, Analytical Clinical Chemistry Class 1 862.2050 2023-08-03
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2009-12-07
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2009-12-07
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

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
K072322 Smith & Nephew, Inc. ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS 2007-09-18
K895079 Buckman Co., Inc. ACE BEADED K-WIRES ACE OLIVE WIRES 1989-09-13
K922193 Osteo AG OSTEO KIRSCHNER WIRE 1992-07-23
K850026 Kirkstil Corp., Inc. ORTHOPEDIC IMPLANT NAILS & PINS 1985-05-20
K963367 Rms Div. RMS K-WIRE 1996-10-30

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-05 Biomet, Inc. 2
Lactosorb pin, 2.0 x 20 mm, sterile; ref. 948205.
Z-0041-05 Linvatec Corp. 2
Ultra Power Burs, Sterile, Single-Use.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021226419. Last updated year: 2026. Please use registration number 3021226419 when referencing this establishment in official correspondence.
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