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    FDA Registration Active 🇲🇾 Malaysia

    Baseplate Tibial Tray Size 1 (MO10412M) M-3211-0001

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    78
    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
    K142649

    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, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH

    Proprietary Names

    Baseplate Tibial Tray Size 1 (MO10412M) M-3211-0001 Tibial EM Guide (MO10420M) M-3220-5002 Tibial Keel Cutting End (MO10428) M-3220-5013 Tibial Cutting Jig - Right (MO10419M) M-3220-5001 CR Pateller Drill (MO10404M) M-3120-5027 Femoral Posterior Chamfer Cutting Guide Size 4 (MO10409M) M-3120-5034 Femoral Anterior Chamfer Cutting Guide Sz 6 (MO10395M) M-3120-5015 Pateller Drill and Cement Clamp (MO10432M) M-3420-5001 Femoral Anterior Chamfer Cutting Guide Sz 5 (MO10394M) M-3120-5014 Gap Gauge insert 13mm (MO10424M) M-3220-5008 Gap Gauge insert 15mm (MO10425M) M-3220-5009 Femoral Sizer Anterior (MO10388M) M-3120-5008 Baseplate Tibial Tray Size 3 (MO10414M) M-3211-0003 Femoral Posterior Chamfer Cutting Guide Size 3 (MO10408M) M-3120-5033 Head Impactor Sz 2 (MO10373M) M-1500-0032 Headed Pin (MO10429M) M-3220-5015 PS Notch Cutting Jig Size 2 (MO10398M) M-3120-5018 Patellar Drill Guide 38mm (MO10437M) M-3420-5007 Femoral Anterior Chamfer Cutting Guide Sz 4 (MO10393M) M-3120-5013 PS Reamer (MO10403M) M-3120-5023 Tibial Cutting Jig - Left (MO10418M) M-3220-5000 Rod Femoral IM (MO10381M) M-3120-5001 Femoral Posterior Chamfer Cutting Guide Size 2 (MO10407M) M-3120-5032 Pin Long (MO10383M) M-3120-5003 Gap Gauge Shim (M-3220-5007) Head Impactor Sz 3 (MO10374M) M-1500-0036 Tibial Broach Guide (MO10431M) M-3220-5019 Cutting Guide Distal Femoral (MO10386M) M-3120-5006 Tibial Baseplate Trial Handle (MO10427M) M-3220-5011 Femoral Posterior Chamfer Cutting Guide Size 5 (MO10410M) M-3120-5035 Patellar Cement Clamp (MO10434M) M-3420-5003 PS Notch Cutting Jig Size 3 (MO10399M) M-3120-5019 Femoral Anterior Chamfer Cutting Guide Sz 2 (MO10391M) M-3120-5011 Femoral Size Posterior (MO10389M) M-3120-5009 Femoral Posterior Chamfer Cutting Guide Size 1 (MO10406M) M-3120-5031 Alignment Guide Distal Femoral (MO10385M) M-3120-5005 Baseplate Tibial Tray Size 5 (MO10416M) M-3211-0005 Gap Gauge insert (MO10423M) M-3220-5007 Alignment Rod (MO10405M) M-3120-5028 PS Notch Cutting Jig Size 1 (MO10397M) M-3120-5017 Femoral Anterior Chamfer Cutting Guide Sz 6 (MO10402M) M-3120-5022 Blade Gauge (MO10396M) M-3120-5016 PS Notch Cutting Jig Size 4 (MO10400M) M-3120-5020 Baseplate Tibial Tray Size 2 (MO10413M) M-3211-0002 Gap Gauge (MO10422M) M-3220-5006 Baseplate Tibial Tray Size 4 (MO10415M) M-3211-0004 Three Step Drill (MO10380M) M-3120-5000 Pin Driver (MO10384) M-3120-5004 Pin Extractor (MO10387M) M-3120-5007 Femoral Anterior Chamfer Cutting Guide Sz 5 (MO10401M) M-3120-5021 Tibial Stylus (MO10421M) M-3220-5004 Tibial EM Alignment Guide Spikeless Top Shaft (MO10430M) M-3220-5016 Femoral Anterior Chamfer Cutting Guide Sz 1 (MO10390M) M-3120-5010 Femoral Anterior Chamfer Cutting Guide Sz 3 (MO10392M) M-3120-5012 Patellar Drill Guide 29mm (MO10433M) M-3420-5002 Femoral Posterior Chamfer Cutting Guide Size 6 (MO10411M) M-3120-5036 Gap Gauge insert 18mm (MO10426M) M-3220-5010 Patellar Drill Guide 32mm (MO10435M) M-3420-5005 Baseplate Tibial Tray Size 6 (MO10417M) M-3211-0006 Alignment Guide Femoral IM (MO10382M) M-3120-5002 Head Impactor Sz 1 (MO10372M) M-1500-0028 Patellar Drill Guide 35mm (MO10435M) M-3420-5006 EVOLUTION# TIBIA MODULAR 2/4/10 STYLUS ASSEMBLY (E2100210) Slap Hammer (M-3220-5005) 6mm Offset Adapter (M-3202-3006) Revision Stems 10mm x 150mm (M-3202-3006) Augment Screw 15mm (M-3202-5015) Patella Trial Size 32mm (M-3411-0070) Modular Tibial Insert Impactor (M-3320-5054) Modular Femoral Driver (M-3120-5050) Patella Trial Size 41mm (M-3411-0100) Modular Tibial Baseplate Impactor (M-3220-5053) Tibial Augment Sz 6 15mm Left (M-3202-4615L) Stem Screw (M-3202-6000) Patellar Drill Guide 41mm (M-3420-5041) Modular PS Notch Inserter (M-3120-5051) Patella Trial Size 38mm (M-3411-0090) M-3220-5056

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)