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    FDA Registration Active 🇺🇸 United States

    Precision Medical Technologies- North Manchester Manufacturing Facility

    Reg #: 3015179588 · FEI: 3015179588 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    10

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    Registration Details

    Registration Name
    Precision Medical Technologies- North Manchester Manufacturing Facility
    Registration Number
    3015179588
    FEI Number
    3015179588
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    400 Beckley Street
    City
    N Manchester
    State
    IN
    ZIP
    46962
    Country
    US

    Regulatory Submissions

    510(k) Number
    K093093

    Owner / Operator

    Firm Name
    Precision Medical Technologies
    Operator Number
    9025575
    Address
    2059 N. POUND DR., --
    City
    Warsaw
    State
    IN
    Postal Code
    46582
    Country
    US
    Correspondent
    Gregory Neher

    Products

    Device Name Product Code
    Bit, Drill HTW
    Wrench HXC
    Screwdriver HXX
    Intervertebral Fusion Device With Bone Graft, Cervical ODP
    Guide, Surgical, Instrument FZX
    Appliance, Fixation, Spinal Intervertebral Body KWQ
    Orthopedic Manual Surgical Instrument LXH
    Tap, Bone HWX
    Bender HXW
    Appliance, Fixation, Spinal Interlaminal KWP

    Establishment Types

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