Data / Medical devices / Hong Kong / I-Medical Asia Company Limited
I-Medical Asia Company Limited: FDA-registered device maker in Kowloon Bay, Hong Kong, 147 510(k) clearances
I-Medical Asia Company Limited is registered with the FDA (registration 3015806723) in Kowloon Bay, Hong Kong. It lists 50 device types. The FDA files 147 510(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
- 3015806723
- Address
- Unit 18, 4/F, Block Bm Proficient Industrial Centre, 6 Wan Kwun Road, Kowloon Bay, Hong Kong, HKG
- Owner or operator
- I-Medical Asia Company Limited (10085603)
- Roles
- Exporter to the US
- First device listed
- July 8, 2022
- Registered through
- 2026
- Brand names listed
- ARTHREX HUMERAL FRACTURE PLATES AND SCREWS, Accessories, Arthroscopic, Apparatus, Traction, Non-Powered, Arthrex 2.5 mm Tenodesis Screw, Arthrex Compression Screws, Arthrex Distal Radius System, Arthrex Fracture Plates, Arthrex Fracture System 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. Newest 100 of 147.
| 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 |
| November 3, 2023 | K232742 | Arthrex FiberTak 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 |
| March 17, 2023 | K230435 | Arthrex 3.9 mm SwiveLock Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 8, 2023 | K222007 | Arthrex Virtual Implant Positioning (VIP) System | QHE | 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 |
| December 20, 2022 | K221031 | Arthrex DualCompression Hindfoot Fusion Nail Implant System | HSB | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 3, 2022 | K222267 | Arthrex 2.4 mm Volar Distal Radius Plate System | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 19, 2022 | K220839 | Arthrex Compression FT Pins | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 14, 2022 | K222078 | Arthrex SoftStitch | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 9, 2022 | K221354 | Arthrex SutureTape | GAT | 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 |
| August 26, 2022 | K222263 | Arthrex Self Punching SwiveLock Suture Anchors | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 29, 2022 | K220937 | Arthrex Mini Fragment System | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 6, 2022 | K220947 | Arthrex Knotless AC Repair Devices | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 13, 2022 | K221099 | Arthrex Self-Punching PushLock Suture Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 2, 2022 | K213837 | Arthrx Fracture Plates | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 17, 2021 | K213644 | Arthrex Knotless Mini TightRopes | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 17, 2021 | K212415 | Arthrex Modular Glenoid System-Titanium Glenosphere | PHX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 25, 2021 | K212146 | Arthrex LoopLoc Knotless Suture | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 7, 2021 | K210050 | Augmented VaultLock Glenoid | KWS | 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 |
| March 25, 2021 | K203834 | Arthrex Patella SuturePlates | HRS | 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 |
| December 16, 2020 | K203180 | Arthrex DynaNite Nitinol Staples | JDR | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 27, 2020 | K203268 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 20, 2020 | K203100 | Arthrex Eclipse Titanium Humeral Head | PKC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 18, 2020 | K202535 | Arthrex FastThread Interference Screw | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 17, 2020 | K202444 | Knotless TensionTight Button Implant System | MBI | 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 |
| September 3, 2020 | K201522 | Arthrex Syndesmosis TightRope XP Buttress Plate Implant System | HTN | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 2, 2020 | K201677 | Arthrex Mesh Plates | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 21, 2020 | K201749 | Arthrex SwiveLock Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 13, 2020 | K200895 | Univers Revers Modular Glenoid System, Half Augment Baseplate | PHX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 30, 2020 | K201786 | Arthrex Mini Hip PushLock | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 27, 2020 | K201132 | Arthrex Compression Screws | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 8, 2020 | K201542 | Arthrex Eclipse Shoulder Prosthesis System | PKC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 8, 2020 | K193345 | Arthrex DynaNite Compression Plate | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 6, 2020 | K201235 | Arthrex MaxForce MTP Compression Plates and Screws | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 29, 2020 | K200068 | Arthrex DynaNite K-Wire | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 17, 2020 | K200433 | iBalance UKA Tibial Tray Implant | HSX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 12, 2020 | K200341 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 10, 2020 | K193156 | Arthrex Mini Comprehensive Fixation System - 1.0mm Screws | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 15, 2020 | K193503 | Arthrex SwiveLock Suture Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| January 10, 2020 | K193372 | Univers Revers Modular Glenoid System (Augemented baseplates) | PHX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 23, 2019 | K191960 | Arthrex Univers Revers Modular Glenoid System | PHX | 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 |
| November 26, 2019 | K191426 | FiberTak Button | 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 |
| October 19, 2019 | K192532 | Arthrex SwiveLock Anchor | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 17, 2019 | K192441 | Arthrex SwiveLock Anchors | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 16, 2019 | K190953 | Arthrex Minimally Invasive Ankle Fusion Plate | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 15, 2019 | K191326 | Arthrex Mini Comprehensive Fixation System 1.4mm & 1.6mm Module | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| October 3, 2019 | K191344 | Arthrex Mini Comprehensive Fixation System 2.0mm & 2.4mm Module | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 13, 2019 | K190288 | Arthrex Tenodesis Button | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 26, 2019 | K183194 | Arthrex Eclipse Shoulder Prosthesis System | QHQ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 11, 2019 | K191226 | Arthrex SwiveLock Suture Anchor | MAI | 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 |
| May 3, 2019 | K190287 | Arthrex DynaNite® PIP (Hammertoe) Implant | HTY | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 17, 2019 | K190728 | Arthrex SwiveLock Anchors | MBI | 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 |
| March 26, 2019 | K183628 | Arthrex TensionLoc System | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 8, 2019 | K182799 | Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads | KWS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 21, 2018 | K181555 | Arthrex Fracture Adapter Hemi Shoulder Prosthesis | KWS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 14, 2018 | K180768 | Arthrex SwiveLock Anchors | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 28, 2018 | K182039 | Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay | PHX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 21, 2018 | K181769 | Arthrex FiberTak Suture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 30, 2018 | K181513 | Arthrex PushLock Tenodesis Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 6, 2018 | K173845 | Arthrex SwiveLock | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| July 26, 2018 | K173656 | Arthrex FibuLock Nail | HSB | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| June 22, 2018 | K180594 | Knotless SutureTak Anchors | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 22, 2018 | K180662 | Arthrex FastThread Interference Screw | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 20, 2018 | K173900 | Arthrex Univers Revers Modular Glenoid System | PHX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 1, 2018 | K173788 | Arthrex Corkscrew FT | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 12, 2018 | K180118 | Arthrex NanoSuture Anchor | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 14, 2017 | K170414 | Arthrex Univers Revers Apex Humeral Stems | PHX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 15, 2017 | K170206 | Arthrex FiberTape Cerclage | JDQ | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 7, 2017 | K171365 | Arthrex Knee Systems | MBH | 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 |
| September 1, 2017 | K170547 | Arthrex Mesh Plate System | HRS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 30, 2017 | K170899 | 27HJ713S | GCJ | Substantially Equivalent | Lg Electronics | accessdata.fda.gov |
| May 26, 2017 | K171296 | SutureTape | GAT | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| February 24, 2017 | K161371 | Sonoma Fifth Metatarsal Repair System | HSB | Substantially Equivalent | Sonoma Orthopedic Products, Inc. | accessdata.fda.gov |
| February 10, 2017 | K162697 | Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal | KWS | Substantially Equivalent | Custom Orthopaedic Solutions, Inc. | accessdata.fda.gov |
| December 15, 2016 | K161060 | Arthrex iBalance UKA System Vitamin E Tibial Bearing | HSX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| November 30, 2016 | K163138 | Clarius Ultrasound System | IYN | Substantially Equivalent | Clarius Mobile Health Corp. | accessdata.fda.gov |
| November 21, 2016 | K161782 | Arthrex Univers Revers Shoulder Prosthesis System | HSD | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| September 9, 2016 | K161581 | Arthrex Synergy RF System | GEI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| August 29, 2016 | K161108 | Arthrex VaultLock Glenoid | KWS | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| April 19, 2016 | K151527 | Arthrex Univers Revers CA Heads and Adapters | HSD | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 24, 2016 | K151342 | Arthrex SwiveLock Anchors | MAI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| March 10, 2016 | K160069 | Sonoma Fibula Repair System | HSB | Substantially Equivalent | Sonoma Orthopedics Products, Inc. | accessdata.fda.gov |
| February 23, 2016 | K151092 | Arthrex Short Suture Anchors | MBI | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Shoulder Prosthesis, Reverse Configuration
- All makers of Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
- All makers of Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- All makers of Washer, Bolt Nut
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
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.