BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads

    K Number: K201657 · Decision Jul 28, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    276
    Same Product Code
    530
    Applicant Total
    2
    Review Days
    405

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads
    K Number
    K201657
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Corin, Ltd.
    Date Received
    June 18, 2020
    Decision Date
    July 28, 2021
    Product Code
    LZO
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LZO), ordered by most recent decision date.

    Z1 Hip System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Avenir® Müller Stem; Avenir Complete™ Hip System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    implantcast Packaging System Update

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    implaFit® short stems

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Coated hip implants

    FDA 510(k)
    FDA Class 2 ·Orthopedic
    View all

    Other Clearances by Corin, Ltd.

    K Number Device Name
    K200888 OMNIBotics Knee System