Data / Medical devices / Canada / Arthrex Logistic Center Canada
Arthrex Logistic Center Canada: FDA-registered device maker in London Ontario, Canada, 19 510(k) clearances
Arthrex Logistic Center Canada is registered with the FDA (registration 3030926959) in London Ontario, Canada. It lists 29 device types. The FDA files 19 510(k) clearances under its listings, the newest dated May 29, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3030926959
- Address
- 580 Sovereign Road, London Ontario, Canada, N5V 4K7
- Owner or operator
- ARTHREX, INC. (1220287)
- Roles
- Exporter to the US
- First device listed
- August 7, 1996
- Registered through
- 2027
- Brand names listed
- 40 L HIGH FLOW INSUFFLATOR F108, AR-200 - Clips, ARTHROSCOPY LEG HOLDER, Accessories, Photographic, For Endoscope (Exclude Light Sources), Apparatus, Traction, Non-Powered, Arthroscopes, CONTINUOUS WAVE III, Camera Heads 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 |
|---|---|---|---|---|---|---|
| May 29, 2024 | K241235 | Arthrex TightRope II | MBI | 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 |
| February 24, 2023 | K223759 | Arthrex SynergyID Endoscopic Imaging System | GCJ | Substantially Equivalent | Arthex, Inc. | accessdata.fda.gov |
| February 2, 2023 | K223284 | SutureLoc Implant | 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 |
| September 4, 2020 | K201134 | Arthrex NanoScope System | GCJ | 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 |
| October 30, 2019 | K190921 | Arthrex Low Profile Screws | HWC | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| December 10, 2018 | K180533 | Procellera Composite Antibacterial Wound Dressing | FRO | Substantially Equivalent | Vomaris Wound Care, 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 |
| March 18, 2008 | K080560 | HENKE SASS WOLF OF AMERICA ARTHROSCOPE | HRX | Substantially Equivalent | Henke Sass Wolf of America, 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 |
| March 20, 2003 | K024291 | ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475 | HRX | Substantially Equivalent | Arthrex, Inc. | accessdata.fda.gov |
| May 3, 2002 | K014068 | ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 | EBW | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | 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 |
| April 23, 1990 | K901035 | FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLE | FST | Substantially Equivalent | Cuda Products Co. | accessdata.fda.gov |
| August 4, 1988 | K882958 | SONY VIDEO PRINTERS, UP SERIES | KQM | Substantially Equivalent | Sony Medical Electronics Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Controller, Foot, Handpiece And Cord
- All makers of Component, Traction, Non-Invasive
- All makers of Fastener, Fixation, Nondegradable, Soft Tissue
- All makers of Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- All makers of Arthroscope
- All makers of Instrument, Manual, Surgical, General Use
Updated May 29, 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.