BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    EVOLUTION® REV TIB HALF AUG SZ 5/6/6+/7 15MM LT MED/RT LAT (E2535151)

    Reg #: 3004889950 · FEI: 3004889950 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Straits Orthopaedics (MFG) Sdn Bhd
    Registration Number
    3004889950
    FEI Number
    3004889950
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2, Lengkok Teluk Kumbar 1, Jalan Teluk Kumbar
    City
    Bayan Lepas Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K162026

    Owner / Operator

    Firm Name
    Straits Orthopaedics (Mfg) Sdn Bhd
    Operator Number
    10048319
    Address
    No. 2 Lengkok Teluk Kumbar, Jalan Teluk Kumbar
    City
    Bayan Lepas
    State
    Pulau Pinang
    Postal Code
    11920
    Country
    MY
    Correspondent
    TH SU

    Products

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

    Proprietary Names

    EVOLUTION® REV TIB HALF AUG SZ 5/6/6+/7 15MM LT MED/RT LAT (E2535151) EVOLUTION® REV TIB HALF AUG SZ 5/6/6+/7 15MM RT MED/LT LAT (E2535152) EVOLUTION® REV TIB HALF AUG SZ 5/6/6+/7 5MM RT MED/LT LAT (E2535052) EVOLUTION® REV TIB HALF AUG SIZE 2+/3/4 15MM LT MED/RT LAT (E2533151) EVOLUTION® REV TIB HALF AUG SIZE 8/8+ 5MM LT MED / RT LAT (E2538051) EVOLUTION® REV TIB HALF AUG SIZE 8/8+ 10MM LT MED / RT LAT (E2538101) EVOLUTION® REV TIB HALF AUG SIZE 2+/3/4 10MM LT MED/RT LAT (E2533101) EVOLUTION® REV TIBIA KEEL ALIGNMENT GUIDE (E2030015) EVOLUTION® REV TIB HALF AUG SIZE 8/8+ 15MM RT MED / LT LAT (E2538152) EVOLUTION® REV TIB HALF AUG SZ 5/6/6+/7 10MM RT MED/LT LAT (E2535102) EVOLUTION® REV TIB HALF AUG SIZE 8/8+ 5MM RT MED / LT LAT (E2538052) EVOLUTION® REV TIB HALF AUG SZ 5/6/6+/7 5MM LT MED/RT LAT (E2535051) EVOLUTION® REV TIB HALF AUG SZ 5/6/6+/7 10MM LT MED/RT LAT (E2535101) EVOLUTION® REV ADAPTER BROACH 50MM (E2230050) EVOLUTION® REV TIB HALF AUG SIZE 2+/3/4 5MM LT MED/RT LAT (E2533051) EVOLUTION® REV TIB HALF AUG SIZE 8/8+ 10MM RT MED / LT LAT (E2538102) EVOLUTION® REV TIBIA OFFSET ALIGNMENT GUIDE (E2030014) EVOLUTION® REV TIB HALF AUG SIZE 8/8+ 15MM LT MED / RT LAT (E2538151) EVOLUTION® REV SP 18MM REAMER SLEEVE (E2005079) EVOLUTION® REV SP KEEL TOWER LOCKING SIZE 2+-8+ (E2003037) EVOLUTION® REV ADAPTER BROACH 25MM (E2230025) EVOLUTION® REV OFFSET REAMER (E2431003)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)