BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Recon 2.7 mm Locking Screw 40 mm (TLR27-40)

    Reg #: 3025603301 · FEI: 3025603301 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    159
    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
    K221558

    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
    Screw, Fixation, Bone HWC
    Plate, Fixation, Bone HRS
    Washer, Bolt Nut HTN

    Proprietary Names

    Recon 2.7 mm Locking Screw 40 mm (TLR27-40) Recon 2.7mm Non-Locking Screw 16mm (TNR27-16) Recon 2.7mm Non-Locking Screw 28mm (TNR27-28) Recon 2.7 mm Locking Screw 38 mm (TLR27-38) Recon 2.7 mm Locking Screw 50 mm (TLR27-50) Recon 2.7 mm Locking Screw 30 mm (TLR27-30) Recon 2.7mm Non-Locking Screw 18mm (TNR27-18) Recon 2.7 mm Locking Screw 34 mm (TLR27-34) Recon 2.7mm Non-Locking Screw 32mm (TNR27-32) Recon 2.7mm Non-Locking Screw 24mm (TNR27-24) TLS25-10 Met FX Locking Screw 2.5x10mm (Light Blue) TLS20-12 Met FX Locking Screw 2x12mm (Magenta) Y PLATE SHORT - ALPHA (TYA-S) T PLATE MEDIUM (TTP-MD) MINI T PLATE MEDIUM (MTTP-M) TLS25-14 Met FX Locking Screw 2.5x14mm (Light Blue) TLS15-22 Met FX Locking Screw 1.5x22mm (Dark Blue) TNS25-12 Met FX Non-Locking Screw 2.5x12mm (Green) TLS25-24 Met FX Locking Screw 2.5x24mm (Light Blue) TLS15-18 Met FX Locking Screw 1.5x18mm (Dark Blue) TNS15-14 Met FX Non-Locking Screw 1.5x14mm (Bronze) L PLATE LONG - ALPHA (TLP-RL) TLS15-16 Met FX Locking Screw 1.5x16mm (Dark Blue) TNS25-30 Met FX Non-Locking Screw 2.5x30mm (Green) ALPHALOK MET FX SADDLE PLATE-MEDIUM (TP-SADM) WRAP Y PLATE - NARROW (TYW-N) TNS25-18 Met FX Non-Locking Screw 2.5x18mm (Green) STRAIGHT PLATE - THREE HOLES (TSP-3S) MINI STRAIGHT PLATE 5 HOLES (MTSP-5S) Y PLATE MEDIUM - ALPHA (TYA-M) TLS15-10 Met FX Locking Screw 1.5x10mm (Dark Blue) TLS20-16 Met FX Locking Screw 2x16mm (Magenta) TNS20-08 Met FX Non-Locking Screw 2x08mm (Gold) TNS20-16 Met FX Non-Locking Screw 2x16mm (Gold) (TNR27-32) 2.7 mm Non-Locking Screw 32 mm TNS20-20 Met FX Non-Locking Screw 2x20mm (Gold) TNS25-20 Met FX Non-Locking Screw 2.5x20mm (Green) (TNR27-16) 2.7 mm Non-Locking Screw 16 mm TLS25-18 Met FX Locking Screw 2.5x18mm (Light Blue) WRAP Y PLATE - WIDE (TYW-W) Y PLATE SHORT - BETA (TYB-S) (TNR27-12) 2.7 mm Non-Locking Screw 12 mm TNS15-16 Met FX Non-Locking Screw 1.5x16mm (Bronze) Recon MTP Plate Large 0D, 53mm Left (TMP53-0L) TLS25-26 Met FX Locking Screw 2.5x26mm (Light Blue) Met FX 1.3/1.3mm Polyaxial x Monoaxial Drill Guide (TTP13-13) Y PLATE MEDIUM - BETA (TYB-M) TNS15-12 Met FX Non-Locking Screw 1.5x12mm (Bronze) (TNR27-14) 2.7 mm Non-Locking Screw 14 mm Recon Non-Locking Screw 3.5x42mm (TNR35-42) MINI Y PLATE MED - ALPHA (MTYA-M) TNR40-55 Recon 4mm Non-Locking Screw 55mm TNR40-70 Recon 4mm Non-Locking Screw 70mm Recon Locking Screw 3.5x46mm (TLR35-46) MINI Y PLATE MED - BETA (MTYB-M) (TNR27-18) 2.7 mm Non-Locking Screw 18 mm TNS20-14 Met FX Non-Locking Screw 2x14mm (Gold) Recon Non-Locking Screw 3.5x44mm (TNR35-44) L PLATE SHORT - BETA (TLP-LS) TNS25-24 Met FX Non-Locking Screw 2.5x24mm (Green) STRAIGHT PLATE - FOUR HOLES (TSP-4S) TLS25-08 Met FX Locking Screw 2.5x08mm (Light Blue) T PLATE SHORT (TTP-SRT) ALPHALOK MET FX SADDLE PLATE-LONG (TP-SADL) TNS15-08 Met FX Non-Locking Screw 1.5x08mm (Bronze) WRAP Y PLATE - MED (TYW-M) STRAIGHT PLATE - SIX HOLES (TSP-6S) TNR40-50 Recon 4mm Non-Locking Screw 50mm TNS15-18 Met FX Non-Locking Screw 1.5x18mm (Bronze) TLS20-14 Met FX Locking Screw 2x14mm (Magenta) TNS25-08 Met FX Non-Locking Screw 2.5x08mm (Green) TLS25-20 Met FX Locking Screw 2.5x20mm (Light Blue) Recon Tab Plate, 35mm 3 Hole (TTP35-3U) (TNR27-10) 2.7 mm Non-Locking Screw 10 mm (TNR27-26) 2.7 mm Non-Locking Screw 26 mm (TNR27-24) 2.7 mm Non-Locking Screw 24 mm Recon Non-Locking Screw 3.5x34mm (TNR35-34) TLS15-14 Met FX Locking Screw 1.5x14mm (Dark Blue) TNS20-10 Met FX Non-Locking Screw 2x10mm (Gold) Recon Locking Screw 3.5x36mm (TLR35-36) Recon 2.7 mm Locking Screw 20 mm (TLR27-20) TLS25-28 Met FX Locking Screw 2.5x28mm (Light Blue) Y PLATE LONG - BETA (TYB-L) Met FX Locking Screw 1.5x08mm (Dark Blue) (TLS15-08) TNS25-10 Met FX Non-Locking Screw 2.5x10mm (Green) TLS20-20 Met FX Locking Screw 2x20mm (Magenta) TLS25-16 Met FX Locking Screw 2.5x16mm (Light Blue) TLS20-08 Met FX Locking Screw 2x08mm (Magenta) Recon Locking Screw 3.5x38mm (TLR35-38) Recon 2.7 mm Locking Screw 28 mm (TLR27-28) TNS15-22 Met FX Non-Locking Screw 1.5x22mm (Bronze) Recon Locking Screw 3.5x44mm (TLR35-44) Recon Non-Locking Screw 3.5x48mm (TNR35-48) Recon 2.7 mm Locking Screw 24 mm (TLR27-24) Recon 2.7mm Non-Locking Screw 26mm (TNR27-26) T PLATE LONG (TTP-LNG) TNR40-65 Recon 4mm Non-Locking Screw 65mm TLS15-12 Met FX Locking Screw 1.5x12mm (Dark Blue) Recon 2.7mm Non-Locking Screw 36mm (TNR27-36) Recon 2.7mm Non-Locking Screw 40mm (TNR27-40) Recon 2.7 mm Locking Screw 26 mm (TLR27-26) TLS25-22 Met FX Locking Screw 2.5x22mm (Light Blue) Recon 2.7mm Non-Locking Screw 12mm (TNR27-12) Recon 2.7 mm Locking Screw 36 mm (TLR27-36) TCS20-25 MET FX 2MM/2.5MM MET COUNTERSINK Met FX 1.8/1.8mm Polyaxial x Monoaxial Drill Guide (TTP18-18) Recon 2.7mm Non-Locking Screw 22mm (TNR27-22) TNS25-16 Met FX Non-Locking Screw 2.5x16mm (Green) TLS15-20 Met FX Locking Screw 1.5x20mm (Dark Blue) Recon 2.7 mm Locking Screw 32 mm (TLR27-32) Recon 2.7mm Non-Locking Screw 10mm (TNR27-10) L PLATE SHORT - ALPHA (TLP-RS) TLS25-30 Met FX Locking Screw 2.5x30mm (Light Blue) MINI STRAIGHT PLATE 6 HOLES (MTSP-6S) STRAIGHT PLATE - SEVEN HOLES (TSP-7S) Recon 2.7 mm Locking Screw 22 mm (TLR27-22) TNS15-10 Met FX Non-Locking Screw 1.5x10mm (Bronze) STRAIGHT PLATE - EIGHT HOLES (TSP-8S) STRAIGHT PLATE - FIVE HOLES (TSP-5S) Met FX 1.1/1.1mm Polyaxial x Monoaxial Drill Guide (TTP11-11) TNS20-12 Met FX Non-Locking Screw 2x12mm (Gold) TNS20-18 Met FX Non-Locking Screw 2x18mm (Gold) TLS25-12 Met FX Locking Screw 2.5x12mm (Light Blue) TNS15-20 Met FX Non-Locking Screw 1.5x20mm (Bronze) Recon Universal Plate, 31mm Left (TLU-31L) TLS20-18 Met FX Locking Screw 2x18mm (Magenta) MINI STRAIGHT PLATE 7 HOLES (MTSP-7S) TNS25-22 Met FX Non-Locking Screw 2.5x22mm (Green) TNS25-26 Met FX Non-Locking Screw 2.5x26mm (Green) TLS20-22 Met FX Locking Screw 2x22mm (Magenta) TNS25-14 Met FX Non-Locking Screw 2.5x14mm (Green) Y PLATE LONG - ALPHA (TYA-L) MINI T PLATE LONG (MTTP-L) L PLATE LONG - BETA (TLP-LL) TNR40-60 Recon 4mm Non-Locking Screw 60mm TNS25-28 Met FX Non-Locking Screw 2.5x28mm (Green) TLS20-10 Met FX Locking Screw 2x10mm (Magenta) (TNR27-34) 2.7 mm Non-Locking Screw 34 mm TNS20-22 Met FX Non-Locking Screw 2x22mm (Gold) (TNR27-30) 2.7 mm Non-Locking Screw 30 mm Recon Non-Locking Screw 3.5x46mm (TNR35-46) (TNR27-20) 2.7 mm Non-Locking Screw 20 mm Recon 2.7mm Non-Locking Screw 14mm (TNR27-14) TNR27-32 (TNR27-30) (TNR27-36) 2.7 mm Non-Locking Screw 36 mm Recon 2.7mm Non-Locking Screw 34mm (TNR27-34) Recon 2.7mm Non-Locking Screw 38mm (TNR27-38) Recon 2.7 mm Locking Screw 18 mm (TLR27-18) (TNR27-22) 2.7 mm Non-Locking Screw 22 mm (TNR27-28) 2.7 mm Non-Locking Screw 28 mm Recon 2.7 mm Locking Screw 10 mm (TLR27-10) Recon Locking Screw 3.5x42mm (TLR35-42) Recon Non-Locking Screw 3.5x38mm (TNR35-38) Recon MTP Plate Small 5D, 40mm Right (TMP40-5R) Recon Non-Locking Screw 3.5x36mm (TNR35-36) Recon 2.7mm Non-Locking Screw 50mm (TNR27-50) Recon Locking Screw 3.5x34mm (TLR35-34) Recon Locking Screw 3.5x48mm (TLR35-48) Recon 2.7mm Non-Locking Screw 20mm (TNR27-20)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)