BEUDAMED
    FDA Registration Active 🇨🇳 China

    LCCK STEM PROV CASE, STR/OFS

    Reg #: 3007539489 · FEI: 3007539489 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    43
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Paragon Medical Device (Changzhou) Co., Ltd.
    Registration Number
    3007539489
    FEI Number
    3007539489
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3A GDH Industrial Park, No. 16 Chuangye Road
    City
    Changzhou Jiangsu
    Country
    CN

    Owner / Operator

    Firm Name
    Paragon Medical
    Operator Number
    9011072
    Address
    8 Matchett Dr., --
    City
    Pierceton
    State
    IN
    Postal Code
    46562
    Country
    US
    Correspondent
    Stephane Langlois

    US Agent

    Business Name
    Paragon Medical
    Contact Name
    Stephane Langlois
    Address
    8 Matchett Dr
    City
    Pierceton
    State
    IN
    ZIP
    46562
    Country
    US
    Email
    [email protected]
    Phone
    435 5355456

    Products

    Device Name Product Code
    Tray, Surgical, Instrument FSM

    Proprietary Names

    LCCK STEM PROV CASE, STR/OFS LCCK ART SURFACE PROV CASE ELEOS™ INSTRUMENTATION TRAY, PIN CADDY, KIT TO TRAY 8 GENERIC STACKABLE LID ASSY WalterLorenz Surgical Assist Arm LCCK FEM CUTTING INST CASE MIS TKA IM LID ELEOS™ INSTRUMENTATION TRAY, TIBIAL RESURFACING TRIALS, TRAY 6 ELEOS™ INSTRUMENTATION TRAY, REAMERS, TRAY 1 ELEOS™ INSTRUMENTATION TRAY, PROXIMAL DISTAL FEMORAL SEGMENTAL TRIALS, TRAY 4 ELEOS™ INSTRUMENTATION TRAY, MALE-MALE MIDSECTION TRIALS, TRAY 12 ELEOS™ INSTRUMENTATION TRAY, ASSEMBLY/DISASSEMBLY INSTRUMENTS, TRAY 2 Tray, Surgical, Instrument ELEOS™ INSTRUMENTATION TRAY, TIBIAL RESURFACING PREPARATION INSTRUMENTS, TRAY 7 NEXGEN FEM RESECT BASE ASSY LCCK STEM PROV BASE, FLUTED LCCK REAMER BASE W/ T-HANDLE ELEOS™ INSTRUMENTATION TRAY, SEGMENTAL STEM TRIALS, TRAY 3 ELEOS™ INSTRUMENTATION TRAY, PROXIMAL TIBIA TRIALS, TRAY 11 ELEOS™ INSTRUMENTATION TRAY, FEMORAL RESURFACING INSTRUMENTS, TRAY 9 ELEOS™ INSTRUMENTATION TRAY, PATELLA INSTRUMENTS, TRAY 10 LCCK FEM AUG & BOX PROV TRAY LCCK BLOCK AUGMENT PROV BASE ELEOS™ INSTRUMENTATION TRAY, TRAY LID STANDARD A.L.P.S. Clavicle Plating System ELEOS™ INSTRUMENTATION TRAY, TRAY LID SMALL ELEOS™ INSTRUMENTATION TRAY, AUGMENT PREPARATION AND TRIALING INSTRUMENTS, TRAY 13 ELEOS™ INSTRUMENTATION TRAY, RESURFACING STEM TRIALS, TRAY 5 ELEOS™ INSTRUMENTATION TRAY, GENERAL RESURFACING INSTRUMENTS, TRAY 8 STERILIZATION BASE TIB TM CONE STERILIZATION TRAY TIB TM CONE VPC Instruments Zimmer Biomet VIPER PRIME CFXFEN X-TAB TRAY VIPER PRIME CFXFEN XTAB TRAY 2 VIPER PRIME SCREW CADDY Persona Modular Case Componet SR LID BASE ASSEMBLY LID Z1 Hip System PRIMARY DELIVERY SYS PRIME TOP IMPLANT TRAY Persona Modular Case Component SR LID BASE ASSEMBLY BASE

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)