BEUDAMED
    FDA Registration Active 🇺🇸 United States

    32-700118

    Reg #: 3010386387 · FEI: 3010386387 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    27
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    SINGLE SOURCE MEDICAL LLC
    Registration Number
    3010386387
    FEI Number
    3010386387
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4506 S State Road 9 57
    City
    Churubusco
    State
    IN
    ZIP
    46723
    Country
    US

    Regulatory Submissions

    510(k) Number
    K153657

    Owner / Operator

    Firm Name
    Single Source Medical LLC
    Operator Number
    10043888
    Address
    4506 IN 9-57
    City
    Churubusco
    State
    IN
    Postal Code
    46723
    Country
    US
    Correspondent
    Tom Harris

    Products

    Device Name Product Code
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
    Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer MBV
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY

    Proprietary Names

    32-700118 32-700079 32-700078 32-700119 32-700084 32-700187 32-700188 32-700117 32-700150 32-700114 32-700082 32-700186 32-700080 32-700153 32-700113 32-700151 VANGUARD XP KNEE SYSTEM 32-700083 32-700116 32-700185 32-700184 32-700149 32-700183 32-700152 32-700148 32-700115 32-700081

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)