Data / Medical devices / Thailand / Device Innovation Company Limited
Device Innovation Company Limited: FDA-registered device maker in Bangkok Krung Thep Maha Nakhon, Thailand, 41 510(k) clearances
Device Innovation Company Limited is registered with the FDA (registration 3012818475) in Bangkok Krung Thep Maha Nakhon, Thailand. It lists 34 device types. The FDA files 41 510(k) clearances under its listings, the newest dated November 15, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012818475
- Address
- 33/333 Soi Ngamwongwan 47 Yak 12 (Chinnakhet 2/10) Tungsonghong Laksi, Bangkok Krung Thep Maha Nakhon, Thailand, 10210
- Owner or operator
- Device Innovation Company Limited (10085496)
- Roles
- Exporter to the US
- First device listed
- June 24, 2022
- Registered through
- 2026
- Brand names listed
- Accessories, Arthroscopic, Apparatus, Traction, Non-Powered, BIT, DRILL, BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL, Bur, Surgical, General & Plastic Surgery, CAMERA, SURGICAL AND ACCESSORIES, CAMERA, TELEVISION, SURGICAL, WITHOUT AUDIO, CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE 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 |
|---|---|---|---|---|---|---|
| November 15, 2023 | K232973 | Arthrex Knee FiberTak® Button Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 22, 2022 | K221396 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 7, 2022 | K221731 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire | MBI | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd. | 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 |
| December 12, 2019 | K193157 | Arthrex 3.9mm Corkscrew Suture Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 26, 2019 | K183194 | Arthrex Eclipse Shoulder Prosthesis System | QHQ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 19, 2019 | K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire | MBI | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd. | 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 |
| September 9, 2016 | K161581 | Arthrex Synergy RF System | GEI | 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 |
| 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 |
| December 18, 2014 | K140855 | ARTHREX SUTURETAK SUTURE ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 25, 2014 | K142863 | Univers Rivers Shoulder Prosthesis System | PHX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 8, 2014 | K141478 | ARTHREX FRACTURE PLATES AND SCREWS | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 10, 2014 | K140328 | CMC MINI TIGHTROPE | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 27, 2013 | K131633 | ARTHREX UNIVERS APEX | KWS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 3, 2013 | K130458 | KNOTLESS FIBERTAK SUTURE ANCHOR | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 5, 2013 | K123241 | ARTHREX FRACTURE PLATES | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 21, 2011 | K112437 | ARTHREX FRACTURE SYSTEM | HTN | 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 |
| October 22, 2010 | K101679 | ARTHREX PUSHLOCK ANCHORS | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 28, 2009 | K091844 | ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS | MAI | 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 |
| August 20, 2007 | K071032 | ARTHREX UNIVERS II SHOULDER PROSTHESIS | KWS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 13, 2006 | K063479 | ARTHREX PUSHLOCK | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 29, 2005 | K052387 | ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX | LZB | 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 |
| November 18, 2003 | K031666 | ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 6, 2002 | K020345 | ARTHREX UNIVERS FRACTURE PROSTHESIS | KWS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 6, 2001 | K010124 | ARTHREX UNIVERS 30 SHOULDER PROSTHESIS | KWS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 25, 1994 | K932699 | ARTHREX AR-8200 SHAVER SYSTEM | HWE | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 19, 1992 | K915721 | MODEL AR-6300 INFUSION PUMP | HRX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Bit, Drill
- All makers of Bur, Surgical, General & Plastic Surgery
- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- All makers of Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- All makers of Fastener, Fixation, Biodegradable, Soft Tissue
- All makers of Screw, Fixation, Bone
Updated November 15, 2023. 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.