BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System

    Reg #: 3009962553 · FEI: 3009962553 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Clariance, Inc.
    Registration Number
    3009962553
    FEI Number
    3009962553
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2547 Farrington St
    City
    Dallas
    State
    TX
    ZIP
    75207
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240872

    Owner / Operator

    Firm Name
    CLARIANCE-SAS
    Operator Number
    10043711
    Address
    18, rue Robespierre
    City
    BEAURAINS
    State
    Pas-de-Calais
    Postal Code
    62217
    Country
    FR

    Products

    Device Name Product Code
    Thoracolumbosacral Pedicle Screw System NKB

    Proprietary Names

    Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System

    Establishment Types

    Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198