Data / Medical devices / Colombia / Arthrex Colombia SAS
Arthrex Colombia SAS: FDA-registered device maker in Bogota Cundinamarca, Colombia, 69 510(k) clearances
Arthrex Colombia SAS is registered with the FDA (registration 3021226419) in Bogota Cundinamarca, Colombia. It lists 48 device types. The FDA files 69 510(k) clearances under its listings, the newest dated July 25, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3021226419
- Address
- Carrera 11 No. 79-35 Piso 9, Bogota Cundinamarca, Colombia, 110221
- Owner or operator
- ARTHREX, INC. (1220287)
- Roles
- Exporter to the US
- First device listed
- January 27, 1994
- Registered through
- 2027
- Brand names listed
- 40 L HIGH FLOW INSUFFLATOR F108, ACL TightRope, ARTHROERESIS IMPLANT, ARTHROSCOPY LEG HOLDER, ARTHROSCOPY PUMP, Accessories, Photographic, For Endoscope (Exclude Light Sources), Apparatus, Traction, Non-Powered, Arthrex Fracture Plates and Screws and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 25, 2024 | K241361 | Arthrex Synergy Vision Endoscopic Imaging System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 15, 2023 | K232973 | Arthrex Knee FiberTak® Button Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 6, 2023 | K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 8, 2023 | K231857 | Arthrex TightRope II | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 18, 2023 | K231113 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 24, 2023 | K223759 | Arthrex SynergyID Endoscopic Imaging System | GCJ | Substantially Equivalent | Arthex, Inc. | accessdata.fda.gov |
| December 22, 2022 | K221396 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 5, 2022 | K221128 | Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 30, 2020 | K203239 | Arthrex Low Profile Screws | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 27, 2020 | K203268 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 18, 2020 | K202535 | Arthrex FastThread Interference Screw | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 4, 2020 | K202581 | Arthrex TightRope II | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 4, 2020 | K201134 | Arthrex NanoScope System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 12, 2020 | K200341 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 6, 2019 | K191651 | Arthrex Nano SwiveLock Suture Anchor | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 17, 2019 | K183395 | Arthrex 2.5 mm Tenodesis Screw | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 21, 2018 | K181769 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 16, 2018 | K173240 | Arthrex PushLock | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 28, 2017 | K172612 | FiberTak DX | MBI | Substantially Equivalent | Arthex, Inc. | accessdata.fda.gov |
| September 14, 2017 | K172385 | Clarius Ultrasound System | IYN | Substantially Equivalent | Clarius Mobile Health Corp. | accessdata.fda.gov |
| November 30, 2016 | K163138 | Clarius Ultrasound System | IYN | Substantially Equivalent | Clarius Mobile Health Corp. | accessdata.fda.gov |
| September 9, 2016 | K161581 | Arthrex Synergy RF System | GEI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 4, 2016 | K153513 | Insufflator 50L FM134 | HIF | Substantially Equivalent | W.O.M. World of Medicine GmbH | accessdata.fda.gov |
| February 12, 2016 | K153218 | Arthrex Synergy UHD4 System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 28, 2015 | K151732 | Arthrex Fracture Plates | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 20, 2015 | K150648 | Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 7, 2015 | K151543 | Graft Delivery Device with Integrated Stylet | FMF | Substantially Equivalent | Micromedics, Inc. (D/B/A Nordson Medical) | accessdata.fda.gov |
| June 19, 2015 | K151230 | Arthrex FiberTak Anchors | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 16, 2015 | K143614 | Arthrex Low Profile Screws | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 16, 2015 | K143139 | Arthrex Fracture System | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 18, 2014 | K141577 | ARTHREX PIP DART | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 8, 2014 | K141478 | ARTHREX FRACTURE PLATES AND SCREWS | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 30, 2014 | K133275 | MINI TIGHTROPE | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 31, 2013 | K132043 | ARTHREX SPEEDCINCH | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 3, 2013 | K130458 | KNOTLESS FIBERTAK SUTURE ANCHOR | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 21, 2012 | K123341 | ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 20, 2012 | K122208 | EXTERNAL FIXATOR SYSTEM | NDK | Substantially Equivalent | Christopher D. Endara | accessdata.fda.gov |
| May 16, 2012 | K121124 | ARTHREX MIXING AND DELIVERY SYSTEM | FMF | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 19, 2011 | K112990 | ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 18, 2011 | K103705 | LOW PROFILE SCREWS | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 5, 2011 | K103060 | ARTHREX TIBIAL GRAFTBOLT | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 22, 2010 | K101679 | ARTHREX PUSHLOCK ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 23, 2010 | K100652 | ACL TIGHTROPE | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 22, 2010 | K093343 | GRAFTY QUICKSET | MQV | Substantially Equivalent | Graftys | accessdata.fda.gov |
| March 18, 2010 | K093912 | ARTHREX TIBIAL GRAFTBOLT | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 6, 2009 | K090107 | MINI TIGHTROPE | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 3, 2009 | K083707 | ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE | HRX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 18, 2008 | K080560 | HENKE SASS WOLF OF AMERICA ARTHROSCOPE | HRX | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| February 11, 2008 | K073149 | MENISCAL CINCH | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 17, 2008 | K071456 | ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 15, 2007 | K071756 | ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE | GCJ | Substantially Equivalent | Pointe Conception Medical, Inc. | accessdata.fda.gov |
| November 29, 2006 | K062466 | ARTHREX INTERFERENCE SCREW | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 29, 2006 | K062747 | ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 29, 2006 | K062365 | ARTHREX ASPIRATE KIT | FMF | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 3, 2006 | K053543 | ARTHREX ARTHOERESIS IMPLANT | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 13, 2005 | K052776 | TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 27, 2005 | K051726 | ARTHREX TENODESIS FAMILY | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 16, 2005 | K043248 | TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS; STAINLESS STEEL. MODEL AR-8921DS | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 5, 2004 | K030837 | 40 L HIGH FLOW INSUFFLATOR F108 | HIF | Substantially Equivalent | W.O.M. World of Medicine AG | accessdata.fda.gov |
| November 18, 2003 | K031666 | ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 20, 2003 | K024291 | ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475 | HRX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 17, 2002 | K023986 | ARTHREX OPES ELECTRODES AND ACCESSORIES | GEI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 7, 2002 | K021434 | ARTHREX FIBERWIRE IN USP SIZES | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 3, 2002 | K022234 | ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 7, 2001 | K002469 | IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) | EBW | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| January 22, 1996 | K953913 | OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES | HRX | Substantially Equivalent | Optus, Inc. | accessdata.fda.gov |
| May 16, 1994 | K941541 | HSV LAPAROSCOPY SET | GCJ | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| March 19, 1992 | K915721 | MODEL AR-6300 INFUSION PUMP | HRX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 23, 1990 | K901035 | FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE | FST | Substantially Equivalent | Cuda Products Co. | accessdata.fda.gov |
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Updated July 25, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.