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    FDA Registration Active 🇲🇾 Malaysia

    EVOLUTION# FEMORAL FINISH IMPACTOR W/ MOD CONNECTION(E1005101)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    46
    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

    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
    Impactor HWA

    Proprietary Names

    EVOLUTION# FEMORAL FINISH IMPACTOR W/ MOD CONNECTION(E1005101) HEAD IMPACTOR (PPR67702) CUP IMPACTOR ADAPTER "PROCOTYL® L / O" SIZE GROUP A (APA09303) LINEAGE# LINER POSITIONER/ IMPACTOR 32mm 15Deg(80003215) FEMORAL HEAD IMPACTOR (4400FI0000) EMBOUT POUR IMPACTEUR (155001) IMPACTOR/EXTRACTOR DOME 54ID (480254DM) STEM GUIDE IMPACTOR "PROFEMUR® Z" (APA-01114) CUP IMPACTOR ADAPTER "PROCOTYL® L / O" SIZE GROUP D (APA09306) TETE A IMPACTION D'INSERT 18 DEG DEBORD=15 D=32 (APA07062) Path Ceramic / Metal Liner Impactor 26mm ID (20070025) DJO EMPOWR KNEE, Impactor Handle, Mach (800-05-024) FINAL STEM IMPACTOR TMF (PPF60200) FOUNDATION IMPACTOR HANDLE (800-01-018) TRANSCEND® INSERT IMPACTOR HANDLE (80000010) PATH® CERAMIC / METAL LINER IMPACTOR 32MM ID (20070024) EVOLUTION® CS / CR FEM HOLDER DRIVER UPTD (E1005113) IMPACTOR FINAL DE COTYLE ANCA FIT (PPR68070) EVOLUTION® FEMORAL PS MODULAR HOLDER DRIVER UPTD (E1005117) ADVANCE® II TIB BASE EXT/IMP NEW - REPLACING K0027224 (K0027227) PATH® CERAMIC / METAL LINER IMPACTOR 28MM ID (20070023) Evolve Pro Impactor 4.5/5.5mm (24981007) TRANSCEND® SHELL IMPACTOR (8000CI00) EVOLUTION® PS FEM HOLDER REPLACEMENT HEAD UPTD (E1005118) Evolve Pro Impactor 6.5/7.5mm (24981008) EVOLUTION® FEMORAL FINISH IMPACTOR REPLACEMENT HEAD (E1005212) Evolve Pro Impactor 8.5/9.5mm (24981009) Evolve Pro Impactor 4.5/5.5mm (NC10956M) Femoral Impactor Head, Exprt (800-01-452) Evolve Pro Impactor 8.5/9.5mm (NC10958M) Evolve Pro Impactor 6.5/7.5mm (NC10957M) Straight Acetabular Impactor, Hip, FMP (80305337) Femoral Head Impactor (803-00-041) EVOLUTION® CS / CR FEM HOLDER DRIVER REPLACEMENT HEAD UPTD (E1005114) CUP IMPACTOR ADAPTER "PROCOTYL® L / O" SIZE GROUP C (APA09305) Impactor Tip MP Cup Inserter, Medium (803-05-280) Evolution® Tibial Base Finish Impactor Replacement Head (E2005212) Tibial Impactor Head, Exprt (801-01-743) 803-15-001 (Straight Acet, Impactor, Empowr) Empowr Acet Dual Mobility, Liner Impactor Extension, Straight (803-15-101) Altivate Anatomic™ Cannulated Impactor (804-07-136) Empowr Acetabular Dual Mobility, Liner Impactor Tip (803-15-103) PERFORM IMPACTOR HANDLE (MWM038) 278-1-10004 Hook Impactor Adapter, SFP (880-1-10101) SPECIAL, EMPOWR ACET. CANNULATED CUP IMPACTOR (S-201494)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)