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    FDA Registration Active 🇲🇾 Malaysia

    Altivate Reverse, Small Socket Insert Trial,40mm, SEMI-CONSTRAINED +4mm OFFSET (804-06-211)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    22
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    STRAITS ORTHOPAEDICS (MFG) SDN BHD
    Registration Number
    3012217062
    FEI Number
    3012217062
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No 2483 Tingkat Perusahaan 4A, Prai Free Industrial Zone
    City
    Perai Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K172351

    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, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Shoulder Prosthesis, Reverse Configuration PHX

    Proprietary Names

    Altivate Reverse, Small Socket Insert Trial,40mm, SEMI-CONSTRAINED +4mm OFFSET (804-06-211) Altivate Reverse, Humeral Socket Shell Trial, Small (804-06-051) Altivate Reverse, Small Socket Insert Trial,36mm, SEMI-CONSTRAINED +4mm OFFSET (804-06-207) Altivate Reverse, Small Socket Insert Trial,32mm, SEMI-CONSTRAINED +4mm OFFSET (804-06-203) Altivate Reverse, Small Socket Insert Trial,40mm, NEUTRAL (804-06-208) Altivate Reverse, Small Socket Insert Trial,40mm, SEMI-CONSTRAINED (804-06-209) Altivate Reverse, Small Socket Insert Trial,32mm, NEUTRAL +4mm OFFSET (804-06-202) Altivate Reverse, Small Socket Insert Trial,36mm, NEUTRAL +4mm OFFSET (804-06-206) Altivate Reverse, Small Socket Insert Trial,32mm, NEUTRAL (804-06-200) Altivate Reverse, Small Socket Insert Trial,32mm, SEMI-CONSTRAINED (804-06-201) Altivate Reverse, Small Socket Insert Trial,40mm, NEUTRAL +4mm OFFSET (804-06-210) Altivate Reverse, Small Socket Insert Trial,36mm, SEMI-CONSTRAINED (804-06-205) Altivate Reverse, Small Socket Insert Trial,36mm, NEUTRAL (804-06-204) AltiVate Reverse Glenoid Guide Handle (804-06-300) ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE (804-06-310) ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD (804-06-311) AltiVate Reverse Glenoid Baseplate Extractor (804-06-345) ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm (804-06-312) ALTIVATE REVERSE GLENOID DUAL TAPER TRIAL, 8mm (804-06-334) ALTIVATE REVERSE WEDGE GLENOID REAMER HANDLE (804-06-313) ALTIVATE REVERSE GLENOID WEDGE REAMER ASSEMBLY FIXTURE (804-06-346) ALTIVATE REVERSE GLENOID DUAL TAPER TRIAL, 6.5mm (804-06-333)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)