BEUDAMED
    FDA Registration Active 🇺🇸 United States

    806 Fixed Driver (806-009)

    Reg #: 3010052483 · FEI: 3010052483 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    71
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    ECA MEDICAL INSTRUMENTS
    Registration Number
    3010052483
    FEI Number
    3010052483
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1107 Tourmaline Drive
    City
    Newbury Park
    State
    CA
    ZIP
    91320
    Country
    US

    Owner / Operator

    Firm Name
    ECA Medical Instruments
    Operator Number
    10042970
    Address
    1107 Tourmaline Drive
    City
    Newbury Park
    State
    CA
    Postal Code
    91320
    Country
    US
    Correspondent
    Janice Grace

    Products

    Device Name Product Code
    Orthopedic Manual Surgical Instrument LXH

    Proprietary Names

    806 Fixed Driver (806-009) 219 Medium Axial HandleTorque Driver 225 In-Line Torque-Driver with Torque-Fast® 905-001 Lumbar Sterile Instrument Kit 230 Large or Offset T-handle Torque Driver with Torque-Fast® 218 Torque Limiter Series 940 Instrument Kit Series 925 DRP Removal Driver System 801-001 Instrument Kit 926 DRP Template System Series 803 Instrument Kits 922 DRP Instrument System Series 219-TXAX-001 Medium Axial Handle Torque Driver 806 Fixed Driver Series 963 NX Nail Accessory Kit (963-001) 802 Instrument Kits (802-004) 921 Instrument Kit (921-003) 940 Instrument Kit (940-001) 921 Instrument Kit (921-002) 919 Instrument Kits (919-002) 921 Instrument Kit (921-004) 806 Fixed Driver (806-004) 218-025 Torque Limiter 803 TruTORQ Adaptor Instrument Kit (803-003) 940 Instrument Kit (940-003) 960 NX Nail Instrument Kit (960-005) 963 NX Nail Accessory Kit (963-003) 219-TXAC-006 Torque Driver 218-022 Torque Limiter 803 TruTORQ T-Handle Instrument Kit (803-004) 802 Instrument Kits (802-007) 802 Instrument Kits (802-003) 803 TruTORQ Adaptor Instrument Kit (803-001) 919 Instrument Kits (919-001) 806 Fixed Driver (806-002) 803 TruTORQ Adaptor Instrument Kit (803-002) 963 NX Nail Accessory Kit (963-005) 802 Instrument Kits (802-001) 940 Instrument Kit (940-002) 921 Instrument Kit (921-001) 921 Instrument Kit (921-005) 806 Fixed Driver (806-003) 801 Instrument Kit (801-005) 219-TXAX-013 Torque Driver 806 Fixed Driver (806-005) 812 T Handle Fixed Driver Series 806 Fixed Driver (806-008) 219-TXAX-012 Torque Driver 976 T10 Driver Kit, AO 960 NX Nail Instrument Kit (960-001) 960 NX Nail Instrument Kit (960-002) 963 NX Nail Accessory Kit (963-006) 812 T Handle Fixed Driver (812-001) 218-036 Torque Limiter 960 NX Nail Instrument Kit (960-004) 960 NX Nail Instrument Kit (960-003) 963 NX Nail Accessory Kit (963-002) 940 Instrument Kit (940-004) 960 NX Nail Instrument Kit (960-006) 219-TXAX-011 Torque Driver 963 NX Nail Accessory Kit (963-004) Orthopedic Cannulated Nail Instrument Pack (964-001) 218-035 Torque Limiter 802 Instrument Kits (802-005) Orthopedic Cannulated Nail Instrument Pack (964-002) 802 Instrument Kits (802-009) 805-001 Instrument Kit Orthopedic Cannulated Nail Instrument Pack (964-003) 801 Instrument Kit (801-003) 802 Instrument Kits (802-008) 801 Instrument Kit (801-007)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device