BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    EVOLVE™ RH PLATE SZ 1 LONG (4910L001)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    44
    Establishment Types
    1
    Classifications
    1

    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
    K033456

    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
    Plate, Fixation, Bone HRS

    Proprietary Names

    EVOLVE™ RH PLATE SZ 1 LONG (4910L001) RHP NON-LOCK SCREW 2 X 20MM (24910020) LOCON-T™ CORTICAL BONE SCREW2.7mm DIAMETER 20mm LENGTH (49000320) LOCON-T™ CORTICAL BONE SCREW2.7mm DIAMETER 22mm LENGTH (49000322) RHP LOCKING SCREW 2 X 28MM (49110428) EVOLVE™ RH PLATE SZ 4 LONG (4910S004) RHP CORTICAL SCREW 2.7 X 14MM (24920014) CORTICAL BONE SCREW2.7mm DIAMETER 12mm LENGTH (49000312) LOCON-T™ CORTICAL BONE SCREW1.8mm DIAMETER 22mm LENGTH (49000222) RHP CORTICAL SCREW 2.7 X 20MM (24920020) LOCON-T™ CORTICAL BONE SCREW1.8mm DIAMETER 30mm LENGTH (49000230) RHP CORTICAL SCREW 2.7 X 22MM (24920022) RHP LOCKING SCREW 2 X 26MM (49110426) RHP NON-LOCK SCREW 2 X 16MM (24910016) EVOLVE™ RH PLATE SZ 2 LONG (4910S002) LOCON-T™ CORTICAL BONE SCREW2.7mm DIAMETER 26mm LENGTH (49000326) EVOLVE™ RH PLATE SZ 3 LONG (4910S003) RHP CORTICAL SCREW 2.7 X 12MM (24920012) RHP LOCKING SCREW 2 X 20MM (49110420) CORTICAL BONE SCREW2.7mm DIAMETER 10mm LENGTH (49000310) LOCON-T™ CORTICAL BONE SCREW2.7mm DIAMETER 24mm LENGTH (49000324) RHP CORTICAL SCREW 2.7 X 26MM (24920026) RHP NON-LOCK SCREW 2 X 14MM (24910014) RHP NON-LOCK SCREW 2 X 12MM (24910012) RHP NON-LOCK SCREW 2 X 26MM (24910026) RHP NON-LOCK SCREW 2 X 24MM (24910024) RHP LOCKING SCREW 2 X 22MM (49110422) EVOLVE™ RH PLATE SZ 4 LONG (4910L004) RHP NON-LOCK SCREW 2 X 18MM (24910018) CORTICAL BONE SCREW2.7mm DIAMETER 16mm LENGTH (49000316) RHP CORTICAL SCREW 2.7 X 16MM (24920016) EVOLVE™ RH PLATE SZ 3 LONG (4910L003) RHP NON-LOCK SCREW 2 X 22MM (24910022) EVOLVE™ RH PLATE SZ 2 LONG (4910L002) RHP LOCKING SCREW 2 X 18MM (49110418) RHP LOCKING SCREW 2 X 24MM (49110424) EVOLVE™ RH PLATE SZ 1 LONG (4910S001) LOCON-T™ CORTICAL BONE SCREW1.8mm DIAMETER 18mm LENGTH (49000218) RHP CORTICAL SCREW 2.7 X 24MM (24920024) CORTICAL BONE SCREW2.7mm DIAMETER 14mm LENGTH (49000314) RHP LOCKING SCREW 2 X 16MM (49110416) RHP CORTICAL SCREW 2.7 X 18MM (24920018) CORTICAL BONE SCREW2.7mm DIAMETER 18mm LENGTH (49000318) RHP LOCKING SCREW 2 X 14MM (49110414)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)