BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    AltiVate Anatomic, Cannulated Center (804-07-151)

    Reg #: 3025603301 · FEI: 3025603301 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    16
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    STRAITS ORTHOPAEDICS (MFG) SDN BHD
    Registration Number
    3025603301
    FEI Number
    3025603301
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1264, Lorong PSPN 1, Penang Science Park North
    City
    Simpang Ampat Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K162024

    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, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
    Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD

    Proprietary Names

    AltiVate Anatomic, Cannulated Center (804-07-151) Altivate Anatomic CS, Humeral Head Trial, 38 x 14 (804-08-017) Altivate Anatomic™ , Humeral Canal Reamer, 12mm (804-07-012) Altivate Anatomic™ , Humeral Canal Reamer, 16mm (804-07-016) Altivate Anatomic CS, Humeral Head Trial, 40 x 14 (804-08-018) Altivate Anatomic CS, Centering Guide (804-08-003) Altivate Anatomic™ , Humeral Canal Reamer, 10mm (804-07-010) Altivate Anatomic™ , Humeral Canal Reamer, 14mm (804-07-014) Exprt Revision Hip, Distal Reamers, 18mm (803-95-018) 804-07-008 AltiVate Anatomic, Humeral Canal Reamer, 8mm 804-07-006 AltiVate Anatomic, Humeral Canal Reamer, 6mm 804-07-003 AltiVate Anatomic, Humeral Head Trial Construct Extractor ALTIVATE ANATOMIC™ CANNULATED CENTER DRILL, 4.8mm (804-07-149) 804-07-002 AltiVate Anatomic, Humeral Head Neck Adaptor, Offset ALTIVATE ANATOMIC™ PERIPHERAL DRILL (804-07-147) Altivate Anatomic™ Cannulated Impactor (804-07-136)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)