BEUDAMED
    FDA Registration Active 🇺🇸 United States

    JANCO, INC.

    Reg #: 3010060157 · FEI: 3010060157 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    19
    Establishment Types
    2
    Classifications
    16

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    Registration Details

    Registration Name
    JANCO, INC.
    Registration Number
    3010060157
    FEI Number
    3010060157
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    50 Goodwin Road
    City
    Rollinsford
    State
    NH
    ZIP
    03869
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191525

    Owner / Operator

    Firm Name
    Janco, Inc.
    Operator Number
    10043068
    Address
    50 Goodwin Road
    City
    Rollinsford
    State
    NH
    Postal Code
    03869
    Country
    US
    Correspondent
    Barbara D Grimes

    Products

    Device Name Product Code
    Orthopedic Manual Surgical Instrument LXH
    Screw, Fixation, Bone HWC
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Washer, Bolt Nut HTN
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained JWJ
    Transducer, Ultrasonic, Diagnostic ITX
    Operating Room Accessories Table Tray FWZ
    Protector, Skin Pressure FMP
    Passer HWQ
    Bedding, Disposable, Medical KME
    Screwdriver HXX
    Bit, Drill HTW
    Powered Laser Surgical Instrument GEX
    Kit, Surgical Instrument, Disposable KDD
    Staple, Fixation, Bone JDR

    Proprietary Names

    SurePass CTR; TrapEZ Fiber-Connect KinematX Suture Anchor PEEK 3mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm ClariTEE probe Pad, Disposable, Traction Boot Leg Holder Pad: Allen (BoxedNon Sterile) Leg Holder Pad: S&N (BoxedNon Sterile) Tensile Tape Shuttle Wire Suture Passer Force DFX Suture; Force DFX Suture-Xtreme PunchTac Suture Anchors Bedding, Disposable, Medical- HDS Disposable Pad Kit; HDS Postless Hip Disposables Kit Interference Screw Insertion Tool GFU-100 NITINEX Surgical Kit; NITINEX Staple Sizer Assembly NITINEX Staple System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device