Data / Medical devices / South Korea / Arthrex Korea Ltd.
Arthrex Korea Ltd.: FDA-registered device maker in Gangnam-gu Seoul, South Korea, 80 510(k) clearances
Arthrex Korea Ltd. is registered with the FDA (registration 3013700547) in Gangnam-gu Seoul, South Korea. It lists 36 device types. The FDA files 80 510(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
- 3013700547
- Address
- Parnas Tower, 20th Floor 521 Teheran-ro, Gangnam-gu Seoul, South Korea, 06164
- Owner or operator
- ARTHREX, INC. (1220287)
- Roles
- Exporter to the US
- First device listed
- January 27, 1994
- Registered through
- 2027
- Brand names listed
- ARTHROERESIS IMPLANT, ARTHROSCOPY LEG HOLDER, Apparatus, Traction, Non-Powered, Arthrex Ankle Fusion Plating System, Arthrex BioComposite SutureTak, Arthrex Distal Extremity Plate System, Arthrex Fracture Plates, 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 |
| 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 |
| August 26, 2022 | K222263 | Arthrex Self Punching SwiveLock Suture Anchors | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 22, 2021 | K202582 | Arthrex SynergyID Endoscopic Imaging System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 1, 2021 | K210994 | Arthrex Beveled FT Screws | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 19, 2021 | K203495 | Arthrex SwiveLock Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 3, 2021 | K203294 | Arthrex Pilon Fusion System | HRS | 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 |
| September 4, 2020 | K201134 | Arthrex NanoScope System | GCJ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 27, 2020 | K201132 | Arthrex Compression Screws | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 12, 2020 | K200341 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 11, 2019 | K191226 | Arthrex SwiveLock Suture Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 21, 2018 | K181769 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 22, 2018 | K180594 | Knotless SutureTak Anchors | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 1, 2018 | K173788 | Arthrex Corkscrew FT | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 28, 2017 | K172612 | FiberTak DX | MBI | Substantially Equivalent | Arthex, Inc. | accessdata.fda.gov |
| September 9, 2016 | K161581 | Arthrex Synergy RF System | GEI | Substantially Equivalent | Arthrex, Inc. | 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 2, 2015 | K143745 | Arthrex Corkscrew and SwiveLock Suture Anchors | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 19, 2015 | K151230 | Arthrex FiberTak Anchors | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 29, 2015 | K150456 | Arthrex Plates, Screws, and Staples | HRS | 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 |
| December 18, 2014 | K140855 | ARTHREX SUTURETAK SUTURE ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 15, 2014 | K141735 | ARTHREX ANKLE FUSION PLATING SYSTEM | HRS | 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 3, 2013 | K131474 | ARTHREX DISTAL RADIUS PLATE SYSTEM | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 5, 2013 | K123241 | ARTHREX FRACTURE PLATES | HRS | 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 |
| September 25, 2012 | K122374 | ARTHREX SUTURE (UHMWPE) | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 21, 2011 | K112437 | ARTHREX FRACTURE SYSTEM | HTN | 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 |
| August 2, 2011 | K111253 | ARTHREX DISTAL EXTREMITY PLATE SYSTEM | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 28, 2011 | K110123 | PCL TIGHTROPE | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 31, 2011 | K110660 | ARTHREX BIOCOMPOSITE SUTURETAK | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 18, 2011 | K103705 | LOW PROFILE SCREWS | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 7, 2011 | K101823 | ARTHREX SWIVELOCK ANCHORS | MAI | 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 |
| March 18, 2010 | K093912 | ARTHREX TIBIAL GRAFTBOLT | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 27, 2009 | K092381 | IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION | HRS | Substantially Equivalent | Ibalance Medical, Inc. | accessdata.fda.gov |
| August 28, 2009 | K091844 | ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS | MAI | 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 |
| January 23, 2009 | K082810 | ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW | MAI | 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 13, 2008 | K080111 | ARTHREX COMPRESSION STAPLE | JDR | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 20, 2007 | K071032 | ARTHREX UNIVERS II SHOULDER PROSTHESIS | KWS | 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 |
| August 3, 2007 | K071176 | MODIFICATION TO: ARTHREX INTERFERENCE SCREW | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 13, 2006 | K063479 | ARTHREX PUSHLOCK | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 29, 2006 | K062466 | ARTHREX INTERFERENCE SCREW | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 19, 2006 | K061863 | ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY | HWC | 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 |
| May 19, 2006 | K060478 | ARTHREX BIO-COMPRESSION SCREW | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 3, 2006 | K053543 | ARTHREX ARTHOERESIS IMPLANT | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 26, 2006 | K053338 | ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS | 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 28, 2005 | K052614 | LOW PROFILE PLATE AND SCREW SYSTEM | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 27, 2005 | K051726 | ARTHREX TENODESIS FAMILY | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 27, 2005 | K050259 | ARTHREX BIO-PIN | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 12, 2005 | K050749 | ARTHREX TAK 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 |
| December 14, 2004 | K043337 | ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 10, 2004 | K041553 | ARTHREX SUTURE GRAFTING KIT | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 8, 2004 | K041965 | ARTHREX HUMERAL FRACTURE PLATES AND SCREWS | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 1, 2004 | K040907 | ARTHREX SMALL FRAGMENT PLATES AND SCREWS | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 22, 2003 | K032187 | ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM | 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 |
| January 8, 2001 | K003227 | BIO-ABSORBABLE CORKSCREW MODEL AR-1920B | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 30, 1997 | K971723 | FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM) | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 10, 1996 | K961228 | KARL STORZ MAGNIFYING ARTHROSOCPES | HRX | Substantially Equivalent | KARL STORZ Endoscopy-America, Inc. | accessdata.fda.gov |
| May 16, 1994 | K941541 | HSV LAPAROSCOPY SET | GCJ | Substantially Equivalent | Henke Sass Wolf of America, Inc. | accessdata.fda.gov |
| January 25, 1994 | K932699 | ARTHREX AR-8200 SHAVER SYSTEM | HWE | Substantially Equivalent | Arthrex, Inc. | 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.