BEUDAMED
    FDA Registration Active 🇳🇿 New Zealand

    ENZTEC LIMITED

    Reg #: 3004641308 · FEI: 3004641308 · Expires 2026
    View on FDA
    Products
    35
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    35

    Registration Details

    Registration Name
    ENZTEC LIMITED
    Registration Number
    3004641308
    FEI Number
    3004641308
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3/17 PRINT PLACE, MIDDLETON
    City
    CHRISTCHURCH Canterbury
    Country
    NZ

    Regulatory Submissions

    510(k) Number
    K230876

    Owner / Operator

    Firm Name
    ENZTEC LIMITED
    Operator Number
    9084846
    Address
    3/17 Print Place, Middleton, --
    City
    Christchurch
    State
    Canterbury
    Postal Code
    8024
    Country
    NZ
    Correspondent
    Kate - Moorhead

    US Agent

    Business Name
    Emergo Global Representation LLC
    Contact Name
    Yong Sun
    Address
    2500 Bee Cave Rd., Bldg. 1, Ste. 300
    City
    Austin
    State
    TX
    ZIP
    78746
    Country
    US
    Email
    [email protected]
    Phone
    512 3279997

    Products

    Device Name Product Code
    Gauge, Depth HTJ
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Guide, Surgical, Instrument FZX
    Orthopedic Stereotaxic Instrument OLO
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented MBF
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Screwdriver HXX
    Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
    Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
    Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
    Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
    Clamp HXD
    Intervertebral Fusion Device With Bone Graft, Lumbar MAX
    Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer HRY
    Orthopedic Manual Surgical Instrument LXH
    Caliper KTZ
    Hook, Bone KIK
    Extractor HWB
    Instrument, Cutting, Orthopedic HTZ
    Table And Attachments, Operating-Room BWN
    Impactor HWA
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Instrument, Compression HWN
    Template HWT
    Tray, Surgical, Instrument FSM
    Reamer HTO
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Rasp HTR
    Retractor GAD

    Establishment Types

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