BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OP Response Spine System

    Reg #: 3006460162 · FEI: 3006460162 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    ORTHOPEDIATRICS, CORP
    Registration Number
    3006460162
    FEI Number
    3006460162
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2850 Frontier Dr
    City
    Warsaw
    State
    IN
    ZIP
    46582
    Country
    US

    Regulatory Submissions

    510(k) Number
    K130655

    Owner / Operator

    Firm Name
    ORTHOPEDIATRICS, CORP
    Operator Number
    9102640
    Address
    2850 Frontier Drive, --
    City
    Warsaw
    State
    IN
    Postal Code
    46582
    Country
    US
    Correspondent
    Ray Garrison

    Products

    Device Name Product Code
    Appliance, Fixation, Spinal Interlaminal KWP
    Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis OSH

    Proprietary Names

    OP Response Spine System Response Spine System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility