BEUDAMED
    FDA Registration Active 🇮🇩 Indonesia

    PSN REV 0 DEG FIX TIB PRV LH D

    Reg #: 3007516837 · FEI: 3007516837 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    44
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PT. TEAM-METAL INDONESIA
    Registration Number
    3007516837
    FEI Number
    3007516837
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    JL BRIGJEN KATAMSO NO7-8,KAWASAN BINTANG INDUSTRI II, TANJUNG UNCANG. P. BATAM
    City
    BATAM Kepulauan Riau
    Country
    ID

    Regulatory Submissions

    510(k) Number
    K191625

    Owner / Operator

    Firm Name
    TEAM-METAL(S) PRIVATE LIMITED
    Operator Number
    10028595
    Address
    31KAKI BUKIT VIEW
    City
    SINGAPORE
    State
    SG-NOTA
    Postal Code
    415964
    Country
    SG

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

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

    Proprietary Names

    PSN REV 0 DEG FIX TIB PRV LH D PSN REV FEM IMPT PAD PSN REV 0 DEG FIX TIB PRV RH C PSN REV FEM NTCH CUT DRL GDE PSN REV 0 DEG FIX TIB PRV LH F PSN REV 0 DEG FIX TIB PRV LH B PSN REV 0 DEG FIX TIB PRV RH D PSN REV 0 DEG MOD TIB PRV LH D PSN REV 0 DEG FIX TIB PRV RH B PSN REV 0 DEG MOD TIB PRV RH A PSN REV 0 DEG FIX TIB PRV LH A PSN REV TIB PER CON IMP SM PSN REV 0 DEG MOD TIB PRV LH F PSN REV 0 DEG FIX TIB PRV LH J PSN REV 0 DEG MOD TIB PRV LH B PSN REV 0 DEG MOD TIB PRV LH J PSN REV 0 DEG FIX TIB PRV LH G PSN REV 0 DEG MOD TIB PRV RH D PSN REV 0 DEG MOD TIB PRV LH E PSN REV 0 DEG MOD TIB PRV RH B PSN REV 0 DEG MOD TIB PRV RH J PSN REV 0 DEG FIX TIB PRV RH G PSN REV TIB PER CON IMP LRG PSN REV 0 DEG FIX TIB PRV RH E PSN REV TIB PER CON IMP MED PSN REV 0 DEG FIX TIB PRV RH J PSN REV 0 DEG FIX TIB PRV RH A PSN REV 0 DEG MOD TIB PRV RH F PSN REV 0 DEG MOD TIB PRV RH G PSN REV 0 DEG FIX TIB PRV RH H PSN REV TIB PER CON IMP FIXTIB PSN REV 0 DEG MOD TIB PRV LH C PSN REV 0 DEG MOD TIB PRV LH A PSN REV TIB IMPT PAD PSN REV 0 DEG FIX TIB PRV RH F PSN REV 0 DEG MOD TIB PRV RH C PSN REV 0 DEG FIX TIB PRV LH E PSN REV 0 DEG MOD TIB PRV LH H PSN REV 0 DEG MOD TIB PRV RH H PSN REV 0 DEG MOD TIB PRV LH G PSN REV 0 DEG MOD TIB PRV RH E PSN REV 0 DEG FIX TIB PRV LH C PSN REV TASP LCK SCR 21-26 PSN REV 0 DEG FIX TIB PRV LH H

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)