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Data / Medical devices / Japan / Arthrex Japan G.K. (Shinjuku)

Arthrex Japan G.K. (Shinjuku): FDA-registered device maker in Shinjuku-ku Tokyo, Japan, 35 510(k) clearances

Arthrex Japan G.K. (Shinjuku) is registered with the FDA (registration 3012470322) in Shinjuku-ku Tokyo, Japan. It lists 31 device types. The FDA files 35 510(k) clearances under its listings, the newest dated July 25, 2024. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Arthrex Japan G.K. (Shinjuku)
FDA registration number
3012470322
Address
Shinjuku NS BLDG 28F 2-4-1 Nishi-Shinjuku, Shinjuku-ku Tokyo, Japan, 1630828
Owner or operator
ARTHREX, INC. (1220287)
Roles
Exporter to the US
First device listed
January 27, 1994
Registered through
2027
Brand names listed
Apparatus, Traction, Non-Powered, Arthrex Distal Extremity Plate System, Arthrex Fracture Plates and Screws, Arthrex Fracture System, Arthrex Mini TightRopes, COMPRESSION STAPLE, Instrument, Special Lens, For Endoscope, Instrument, manual, surgical, general use and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, ArthroscopicNBH1Exporter to the USaccessdata.fda.gov
Apparatus, Traction, Non-PoweredHST1Exporter to the USaccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Exporter to the USaccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Exporter to the USaccessdata.fda.gov
Fastener, Fixation, Biodegradable, Soft TissueMAI2Exporter to the USaccessdata.fda.gov
Fastener, Fixation, Nondegradable, Soft TissueMBI2Exporter to the USaccessdata.fda.gov
Guide, Drill, LigamentLXI1Exporter to the USaccessdata.fda.gov
Instrument, BiopsyKNW2Exporter to the USaccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Exporter to the USaccessdata.fda.gov
Instrument, Special Lens, For EndoscopeFEI1Exporter to the USaccessdata.fda.gov
Insufflator, Endoscopic Vessel HarvestingOSV2Exporter to the USaccessdata.fda.gov
Insufflator, LaparoscopicHIF2Exporter to the USaccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Exporter to the USaccessdata.fda.gov
Light, Surgical, FiberopticFST2Exporter to the USaccessdata.fda.gov
Needle, Suturing, DisposableGAB1Exporter to the USaccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Exporter to the USaccessdata.fda.gov
Plate, Fixation, BoneHRS2Exporter to the USaccessdata.fda.gov
Platelet And Plasma Separator For Bone Graft HandlingORG2Exporter to the USaccessdata.fda.gov
Prosthesis, Shoulder, Hemi-, Humeral, Metallic UncementedHSD2Exporter to the USaccessdata.fda.gov
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS2Exporter to the USaccessdata.fda.gov
Punch, SurgicalLRY1Exporter to the USaccessdata.fda.gov
Screw, Fixation, BoneHWC2Exporter to the USaccessdata.fda.gov
Shoulder Arthroplasty Implantation SystemQHE2Exporter to the USaccessdata.fda.gov
Shoulder Prosthesis, Reverse ConfigurationPHX2Exporter to the USaccessdata.fda.gov
Staple, Fixation, BoneJDR2Exporter to the USaccessdata.fda.gov
Suture, Nonabsorbable, Synthetic, PolyethyleneGAT2Exporter to the USaccessdata.fda.gov
Syringe, PistonFMF2Exporter to the USaccessdata.fda.gov
System, Image Processing, RadiologicalLLZ2Exporter to the USaccessdata.fda.gov
System, X-Ray, AngiographicIZI2Exporter to the USaccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Exporter to the USaccessdata.fda.gov
Washer, Bolt NutHTN2Exporter to the USaccessdata.fda.gov

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
July 25, 2024K241361Arthrex Synergy Vision Endoscopic Imaging SystemGCJSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
April 10, 2023K230366Arthrex Univers Revers Monoblock Stem Size 4/33PHXSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
March 8, 2023K222007Arthrex Virtual Implant Positioning (VIP) SystemQHESubstantially EquivalentArthrex, Inc.accessdata.fda.gov
February 24, 2023K223759Arthrex SynergyID Endoscopic Imaging SystemGCJSubstantially EquivalentArthex, Inc.accessdata.fda.gov
September 14, 2022K222078Arthrex SoftStitchGATSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
September 7, 2022K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWireMBISubstantially EquivalentT.A.G. Medical Products Corporation, Ltd.accessdata.fda.gov
August 26, 2022K222263Arthrex Self Punching SwiveLock Suture AnchorsMAISubstantially EquivalentArthrex, Inc.accessdata.fda.gov
August 11, 2022K222161Arthrex Knotless FiberTak Biceps Suture AnchorMBISubstantially EquivalentArthrex, Inc.accessdata.fda.gov
June 6, 2022K220947Arthrex Knotless AC Repair DevicesHTNSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
May 19, 2022K221232Univers Revers Humeral Cup ImplantHSDSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
May 13, 2022K221099Arthrex Self-Punching PushLock Suture AnchorMAISubstantially EquivalentArthrex, Inc.accessdata.fda.gov
November 19, 2021K213213Arthrex Vortex Threaded Bone Marrow Recovery NeedleKNWSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
June 1, 2021K210994Arthrex Beveled FT ScrewsHWCSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
February 3, 2021K203294Arthrex Pilon Fusion SystemHRSSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
December 30, 2020K203239Arthrex Low Profile ScrewsHWCSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
November 27, 2020K203268Arthrex FiberTak Suture AnchorMBISubstantially EquivalentArthrex, Inc.accessdata.fda.gov
July 6, 2020K201235Arthrex MaxForce MTP Compression Plates and ScrewsHRSSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
April 20, 2018K173900Arthrex Univers Revers Modular Glenoid SystemPHXSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
December 14, 2017K170414Arthrex Univers Revers Apex Humeral StemsPHXSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
November 21, 2016K161782Arthrex Univers Revers Shoulder Prosthesis SystemHSDSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
September 9, 2016K161581Arthrex Synergy RF SystemGEISubstantially EquivalentArthrex, Inc.accessdata.fda.gov
March 4, 2016K153513Insufflator 50L FM134HIFSubstantially EquivalentW.O.M. World of Medicine GmbHaccessdata.fda.gov
August 28, 2015K151732Arthrex Fracture PlatesHRSSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
August 20, 2015K150648Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mmMBISubstantially EquivalentArthrex, Inc.accessdata.fda.gov
November 25, 2014K142863Univers Rivers Shoulder Prosthesis SystemPHXSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
July 8, 2014K141478ARTHREX FRACTURE PLATES AND SCREWSHRSSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
January 30, 2014K133275MINI TIGHTROPEHTNSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
December 21, 2011K112437ARTHREX FRACTURE SYSTEMHTNSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
August 2, 2011K111253ARTHREX DISTAL EXTREMITY PLATE SYSTEMHRSSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
February 13, 2008K080111ARTHREX COMPRESSION STAPLEJDRSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
September 29, 2006K062365ARTHREX ASPIRATE KITFMFSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
September 28, 2005K052614LOW PROFILE PLATE AND SCREW SYSTEMHRSSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
July 1, 2004K040907ARTHREX SMALL FRAGMENT PLATES AND SCREWSHRSSubstantially EquivalentArthrex, Inc.accessdata.fda.gov
May 16, 1994K941541HSV LAPAROSCOPY SETGCJSubstantially EquivalentHenke Sass Wolf of America, Inc.accessdata.fda.gov
April 23, 1990K901035FIBER OPTIC LIGHT GUIDE OR FIBER OPTIC CABLEFSTSubstantially EquivalentCuda 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.