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    FDA Registration Active 🇲🇾 Malaysia

    863-1-14009 Uni Tibial Insert Trial Size 4 x 9mm SFP

    Reg #: 3025603301 · FEI: 3025603301 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    63
    Establishment Types
    1
    Classifications
    1

    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
    K211471

    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, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer HSX

    Proprietary Names

    863-1-14009 Uni Tibial Insert Trial Size 4 x 9mm SFP 863-1-16009 Uni Tibial Insert Trial Size 6 x 9mm SFP 863-1-13007 Uni Tibial Insert Trial Size 3 x 7mm SFP 861-1-12401 Uni Femoral Drill-Thru Trial Medial Size 4 Left SFP 863-1-16011 Uni Tibial Insert Trial Size 6 x 11mm SFP 861-1-12101 Uni Femoral Drill-Thru Trial Medial Size 1 Left SFP 863-1-14011 Uni Tibial Insert Trial Size 4 x 11mm SFP 861-1-12402 Uni Femoral Drill-Thru Trial Medial Size 4 Right SFP 863-1-17007 Uni Tibial Insert Trial Size 7 x 7mm SFP 863-1-16006 Uni Tibial Insert Trial Size 6 x 6mm SFP 861-1-12802 Uni Femoral Drill-Thru Trial Medial Size 8 Right SFP 861-1-12502 Uni Femoral Drill-Thru Trial Medial Size 5 Right SFP 861-1-12801 Uni Femoral Drill-Thru Trial Medial Size 8 Left SFP 863-1-17006 Uni Tibial Insert Trial Size 7 x 6mm SFP 863-1-15007 Uni Tibial Insert Trial Size 5 x 7mm SFP 863-1-12011 Uni Tibial Insert Trial Size 2 x 11mm SFP 861-1-12702 Uni Femoral Drill-Thru Trial Medial Size 7 Right SFP 863-1-14010 Uni Tibial Insert Trial Size 4 x 10mm SFP 863-1-11009 Uni Tibial Insert Trial Size 1 x 9mm SFP 863-1-11007 Uni Tibial Insert Trial Size 1 x 7mm SFP 863-1-12009 Uni Tibial Insert Trial Size 2 x 9mm SFP 861-1-12602 Uni Femoral Drill-Thru Trial Medial Size 6 Right SFP 861-1-12201 Uni Femoral Drill-Thru Trial Medial Size 2 Left SFP Uni Femoral Trial Medial Size 7 Right SFP (861-1-11712) 861-1-12102 Uni Femoral Drill-Thru Trial Medial Size 1 Right SFP 863-1-11008 Uni Tibial Insert Trial Size 1 x 8mm SFP 863-1-13008 Uni Tibial Insert Trial Size 3 x 8mm SFP Uni Femoral Trial Medial Size 8 Left SFP (861-1-11811) 861-1-12701 Uni Femoral Drill-Thru Trial Medial Size 7 Left SFP 861-1-12301 Uni Femoral Drill-Thru Trial Medial Size 3 Left SFP 863-1-17010 Uni Tibial Insert Trial Size 7 x 10mm SFP 863-1-13006 Uni Tibial Insert Trial Size 3 x 6mm SFP 863-1-17011 Uni Tibial Insert Trial Size 7 x 11mm SFP 861-1-12601 Uni Femoral Drill-Thru Trial Medial Size 6 Left SFP 862-1-16001 Uni Knee Tibial Tray Trial Size 6 Left SFP 863-1-16008 Uni Tibial Insert Trial Size 6 x 8mm SFP 863-1-12010 Uni Tibial Insert Trial Size 2 x 10mm SFP 863-1-16007 Uni Tibial Insert Trial Size 6 x 7mm SFP 863-1-17008 Uni Tibial Insert Trial Size 7 x 8mm SFP Uni Femoral Trial Medial Size 7 Left SFP (861-1-11711) 863-1-15009 Uni Tibial Insert Trial Size 5 x 9mm SFP 863-1-11006 Uni Tibial Insert Trial Size 1 x 6mm SFP 863-1-12006 Uni Tibial Insert Trial Size 2 x 6mm SFP 863-1-12008 Uni Tibial Insert Trial Size 2 x 8mm SFP 863-1-13011 Uni Tibial Insert Trial Size 3 x 11mm SFP 863-1-11011 Uni Tibial Insert Trial Size 1 x 11mm SFP 863-1-16010 Uni Tibial Insert Trial Size 6 x 10mm SFP 863-1-14006 Uni Tibial Insert Trial Size 4 x 6mm SFP 861-1-12202 Uni Femoral Drill-Thru Trial Medial Size 2 Right SFP 863-1-15010 Uni Tibial Insert Trial Size 5 x 10mm SFP 863-1-12007 Uni Tibial Insert Trial Size 2 x 7mm SFP 863-1-14008 Uni Tibial Insert Trial Size 4 x 8mm SFP 863-1-14007 Uni Tibial Insert Trial Size 4 x 7mm SFP 861-1-12302 Uni Femoral Drill-Thru Trial Medial Size 3 Right SFP 863-1-11010 Uni Tibial Insert Trial Size 1 x 10mm SFP 863-1-15008 Uni Tibial Insert Trial Size 5 x 8mm SFP 863-1-15011 Uni Tibial Insert Trial Size 5 x 11mm SFP 861-1-12501 Uni Femoral Drill-Thru Trial Medial Size 5 Left SFP 863-1-13010 Uni Tibial Insert Trial Size 3 x 10mm SFP 863-1-17009 Uni Tibial Insert Trial Size 7 x 9mm SFP 863-1-13009 Uni Tibial Insert Trial Size 3 x 9mm SFP 863-1-15006 Uni Tibial Insert Trial Size 5 x 6mm SFP Uni Femoral Trial Medial Size 8 Right SFP (861-1-11812)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)