BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    SALVATION™ L BRACKET (SEF11113)

    Reg #: 3004889950 · FEI: 3004889950 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    21
    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
    K180832

    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
    Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component KTT

    Proprietary Names

    SALVATION™ L BRACKET (SEF11113) SALVATION™ 180MM TAB FOOT RING (SEF09180) SALVATION™ EXTENSION PLATE LGE (SEF11101) SALVATION™ 140MM TAB FOOT RING (SEF09140) SALVATION™ 160MM TAB FOOT RING (SEF09160) SALVATION™ 180MM HF RING HINDFOOT HOLES (SEF11180) SALVATION™ UNIVERSAL 1/8 RING TABBED (SEF18222) SALVATION™ FRAME 220MM ASSEMBLY (SEFA2220) Salvation™ Frame 200mm Assembly (SEFA2200) SALVATION™ L BRACKET LGE (SEF11115) SALVATION™ FRAME 180MM ASSEMBLY (SEFA2180) SALVATION™ 160MM HF RING HINDFOOT HOLES (SEF11160) SALVATION™ 140MM HF RING HINDFOOT HOLES (SEF11140) SALVATION™ EXTENSION PLATE (SEF11100) SALVATION™ LINEAR DISTRACTOR (SEF11009) SALVATION™ 200MM DISTAL RING (SEF16200) SALVATION™ FRAME 160MM (SEFA2160) SALVATION™ WIRE BOLT 2MM (SEF10011) SALVATION™ 140MM DISTAL RING (SEF16140) SALVATION™ 160MM DISTAL RING (SEF16160) SALVATION™ 180MM DISTAL RING (SEF16180)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)