BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TC Prim Fixed Tib Insert VKS CR LT 6/12

    Reg #: 3002907620 · FEI: 3002907620 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    139
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics US LLC
    Registration Number
    3002907620
    FEI Number
    3002907620
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1700 College Blvd.
    City
    West Memphis
    State
    AR
    ZIP
    72301
    Country
    US

    Regulatory Submissions

    510(k) Number
    K072858

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH

    Proprietary Names

    TC Prim Fixed Tib Insert VKS CR LT 6/12 PLUSTC Pri Fixed Tibl Comp PLUS VKS RT 6 Pri Fixed Tibl Comp PLUS VKS LT 8 TC Prim Fixed Tib Insert VKS CR LT 8/20 TC PRIM FIXED TIB INSERT VKS CS RT 8/14 TC PRIM FIXED TIB INSERT VKS CS LT 10/20 TC PRIM FIXED TIB INSERT VKS CS RT 12/17 TC PRIM FIXED TIB INSERT VKS CS RT 6/10 TC Prim Fixed Tib Insert VKS CR LT 10/14 TC PRIM FIXED TIB INSERT VKS CS LT 4/12 PLUSTC Pri Fixed Tibl Comp VKS RT 12 TC PRIM FIXED TIB INSERT VKS CS RT 8/20 PLUSTC Pri Fixed Tibl CEM VKS LT 10 TC Prim Fixed Tib Insert VKS CR RT 8/10 TC PRIM FIXED TIB INSERT VKS CS RT 8/17 TC Prim Fixed Tib Insert VKS CR LT 4/17 TC PRIM FIXED TIB INSERT VKS CS RT 10/12 TC PRIM FIXED TIB INSERT VKS CS RT 12/12 TC Prim Fixed Tib Insert VKS CR RT 6/20 TC PRIM FIXED TIB INSERT VKS CS LT 2/12 TC Prim Fixed Tib Insert VKS CR RT 4/14 TC PRIM FIXED TIB INSERT VKS CS LT 6/17 TC Prim Fixed Tib Insert VKS CR RT 12/14 TC PRIM FIXED TIB INSERT VKS CS RT 2/10 TC Prim Fixed Tib Insert VKS CR RT 4/12 TC PRIM FIXED TIB INSERT VKS CS LT 8/12 PLUSTC Pri Fixed Tibl CEM PLUS VKS LT 4 PLUSTC Pri Fixed Tibl Comp VKS RT 12 TC Prim Fixed Tib Insert VKS CR LT 4/14 TC PRIM FIXED TIB INSERT VKS CS RT 6/12 TC PRIM FIXED TIB INSERT VKS CS LT 12/10 TC Prim Fixed Tib Insert VKS CR LT 6/20 TC PRIM FIXED TIB INSERT VKS CS LT 12/14 TC PRIM FIXED TIB INSERT VKS CS LT 2/17 TC Prim Fixed Tib Insert VKS CR LT 12/10 TC Prim Fixed Tib Insert VKS CR RT 4/17 TC Prim Fixed Tib Insert VKS CR LT 8/12 TC Prim Fixed Tib Insert VKS CR RT 8/17 TC Prim Fixed Tib Insert VKS CR LT 12/20 TC Prim Fixed Tib Insert VKS CR RT 10/20 TC PRIM FIXED TIB INSERT VKS CS LT 6/20 TC PRIM FIXED TIB INSERT VKS CS LT 2/14 TC Prim Fixed Tib Insert VKS CR RT 2/12 PLUSTC Pri Fixed Tibl CEM PLUS VKS RT 6 TC PRIM FIXED TIB INSERT VKS CS RT 4/12 TC PRIM FIXED TIB INSERT VKS CS RT 8/10 PLUSTC Pri Fixed Tibl Comp PLUS VKS RT 8 TC PRIM FIXED TIB INSERT VKS CS LT 12/20 TC PRIM FIXED TIB INSERT VKS CS RT 10/10 TC PRIM FIXED TIB INSERT VKS CS LT 10/17 TC PRIM FIXED TIB INSERT VKS CS LT 6/12 PLUSTC Pri Fixed Tibl Comp PLUS VKS LT 2 TC Prim Fixed Tib Insert VKS CR LT 4/10 TC PRIM FIXED TIB INSERT VKS CS LT 4/20 TC PRIM FIXED TIB INSERT VKS CS LT 4/14 TC Prim Fixed Tib Insert VKS CR RT 12/12 TC PRIM FIXED TIB INSERT VKS CS RT 6/20 PLUSTC Pri Fixed Tibl CEM PLUS VKS RT 8 TC PRIM FIXED TIB INSERT VKS CS RT 4/14 TC Prim Fixed Tib Insert VKS CR LT 10/17 TC PRIM FIXED TIB INSERT VKS CS RT 4/10 TC PRIM FIXED TIB INSERT VKS CS RT 2/12 TC Prim Fixed Tib Insert VKS CR LT 4/12 TC PRIM FIXED TIB INSERT VKS CS LT 6/10 TC PRIM FIXED TIB INSERT VKS CS LT 6/14 TC PRIM FIXED TIB INSERT VKS CS RT 12/10 PLUSTC Pri Fixed Tibl Comp PLUS VKS RT 2 PLUSTC Pri Fixed Tibl CEM PLUS VKS RT 2 TC Prim Fixed Tib Insert VKS CR RT 2/17 TC Prim Fixed Tib Insert VKS CR RT 4/20 TC Prim Fixed Tib Insert VKS CR RT 8/12 PLUSTC Pri Fixed Tibl CEM PLUS VKS RT 4 TC PRIM FIXED TIB INSERT VKS CS LT 8/20 TC Prim Fixed Tib Insert VKS CR RT 4/10 TC Prim Fixed Tib Insert VKS CR LT 2/10 PLUSTC Pri Fixed Tibl Comp PLUS VKS LT 4 TC Prim Fixed Tib Insert VKS CR RT 6/17 TC Prim Fixed Tib Insert VKS CR LT 12/17 TC PRIM FIXED TIB INSERT VKS CS LT 12/12 TC Prim Fixed Tib Insert VKS CR LT 6/17 TC PRIM FIXED TIB INSERT VKS CS RT 6/17 TC Prim Fixed Tib Insert VKS CR RT 2/20 TC PRIM FIXED TIB INSERT VKS CS RT 12/20 TC Prim Fixed Tib Insert VKS CR RT 6/14 TC PRIM FIXED TIB INSERT VKS CS LT 10/14 TC Prim Fixed Tib Insert VKS CR RT 8/20 TC Prim Fixed Tib Insert VKS CR LT 2/20 TC Prim Fixed Tib Insert VKS CR LT 2/17 TC PRIM FIXED TIB INSERT VKS CS LT 2/10 TC Prim Fixed Tib Insert VKS CR RT 2/10 TC Prim Fixed Tib Insert VKS CR LT 2/12 TC Prim Fixed Tib Insert VKS CR LT 6/14 TC Prim Fixed Tib Insert VKS CR RT 2/14 TC Prim Fixed Tib Insert VKS CR LT 2/14 TC PRIM FIXED TIB INSERT VKS CS RT 10/14 TC Prim Fixed Tib Insert VKS CR LT 8/17 PLUSTC Pri Fixed Tibl CEM PLUS VKS LT 8 TC PRIM FIXED TIB INSERT VKS CS LT 4/10 PLUSTC Pri Fixed Tibl CEM PLUS VKS LT 2 TC PRIM FIXED TIB INSERT VKS CS RT 4/17 TC PRIM FIXED TIB INSERT VKS CS LT 10/12 TC PRIM FIXED TIB INSERT VKS CS RT 2/20 TC Prim Fixed Tib Insert VKS CR LT 6/10 TC Prim Fixed Tib Insert VKS CR LT 8/10 TC PRIM FIXED TIB INSERT VKS CR RT 0/20 TC PRIM FIXED TIB INSERT VKS CS RT 12/14 TC Prim Fixed Tib Insert VKS CR RT 12/20 TC Prim Fixed Tib Insert VKS CR LT 8/14 TC PRIM FIXED TIB INSERT VKS CS LT 10/10 TC Prim Fixed Tib Insert VKS CR RT 10/10 TC Prim Fixed Tib Insert VKS CR LT 10/10 PLUSTC Pri Fixed Tibl Comp VKS LT 10 TC Prim Fixed Tib Insert VKS CR LT 12/14 TC PRIM FIXED TIB INSERT VKS CS RT10/20 TC PRIM FIXED TIB INSERT VKS CS LT 2/20 TC PRIM FIXED TIB INSERT VKS CS RT 2/14 TC PRIM FIXED TIB INSERT VKS CS RT 8/12 PLUSTC Pri Fixed Tibl Comp PLUS VKS LT 6 TC PRIM FIXED TIB INSERT VKS CS RT 2/17 PLUSTC Pri Fixed Tibl Comp VKS RT 10 TC Prim Fixed Tib Insert VKS CR RT 6/10 TC Prim Fixed Tib Insert VKS CR LT 4/20 TC PRIM FIXED TIB INSERT VKS CS LT 8/17 TC Prim Fixed Tib Insert VKS CR RT 12/17 TC PRIM FIXED TIB INSERT VKS CS LT 8/10 TC Prim Fixed Tib Insert VKS CR RT 6/12 TC PRIM FIXED TIB INSERT VKS CS RT 6/14 TC PRIM FIXED TIB INSERT VKS CS RT 10/17 TC PRIM FIXED TIB INSERT VKS CS LT 4/17 TC Prim Fixed Tib Insert VKS CR LT 10/20 TC PRIM FIXED TIB INSERT VKS CS RT 4/20 TC Prim Fixed Tib Insert VKS CR RT 8/14 TC PRIM FIXED TIB INSERT VKS CS LT 12/17 TC Prim Fixed Tib Insert VKS CR LT 10/12 TC Prim Fixed Tib Insert VKS CR RT 12/10 TC Prim Fixed Tib Insert VKS CR LT 12/12 TC PRIM FIXED TIB INSERT VKS CS LT 8/14 PLUSTC Pri Fixed Tibl Comp VKS LT 12 PLUSTC Pri Fixed Tibl Comp PLUS VKS RT 4

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)