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    FDA Registration Active 🇲🇾 Malaysia

    11.5mm Intertan Long Nail Left (2m Bow) 38cm 125D (81050643)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    154
    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
    K040212

    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
    Nail, Fixation, Bone JDS

    Proprietary Names

    11.5mm Intertan Long Nail Left (2m Bow) 38cm 125D (81050643) INTERTAN 11.5MM X 38CM 125D RIGHT (71675248) Intertan 10S Long Nail Right 10mm x 46cm 125Deg (81107346) INTERTAN 1.5 11.5MM X 36CM 125D LEFT (71676555) 10mm Intertan Short Nail Universal (18cm) 130D (81047292) 10mm Intertan Long Nail Left (1.5m Bow) - 36cm 125D (81087335) Intertan 10S Long Nail Left 10mm x 38cm 130deg (71675514) 11.5mm Intertan Long Nail Left (2m Bow) 38cm 130D (81047303) 10mm Intertan Long Nail Left - 38cm 130D (71675269) INTERTAN 11.5MM X 40CM 130D RIGHT (71675294) Intertan 10S Long Nail Left 10mm x 32cm 130deg (71675508) Intertan 10S Long Nail Right 10mm x 28cm 125deg (71675525) Intertan 10S Long Nail Left 10mm x 30cm 130deg (71675506) Intertan 10S Long Nail Right 10mm x 32cm 130deg (71675530) 10mm Intertan Short Nail Universal (18cm) 125D (81051254) 10mm Intertan Long Nail Left - 38cm 125D (71676513) INTERTAN 11.5MM X 36CM 130D LEFT (71675289) 11.5mm Intertan Long Nail Right - 34cm 125D (71675244) 10mm Intertan Long Nail Right (2m Bow) 40cm 125D (81050592) 10mm Intertan Long Nail Right - 32cm 130D (71675264) 11.5mm Intertan Long Nail Right - 34cm 130D (71675288) 11.5mm Intertan Long Nail Left (1.5m Bow) - 36cm 125D (81087339) 11.5mm Intertan Long Nail Left (2m Bow) 36cm 130D (81047301) 11.5mm Intertan Short Nail Universal - 20cm 130D (81051246) Intertan 10S Long Nail Right 10mm x 46cm 130Deg (81107547) 10mm Intertan Long Nail Right (1.5m Bow) - 36cm 125D (81087336) 11.5mm Intertan Long Nail Right (2m Bow) 34cm 130D (81047300) 10mm Intertan Long Nail Right (2m Bow) 36cm 125D (81050584) INTERTAN 10MM X 36CM 125D LEFT (71675223) 11.5mm Intertan Long Nail Left - 34cm 125D (71675243) Intertan 10S Long Nail Right 10mm x 32cm 125deg (71675529) Intertan 10S Long Nail Right 10mm x 44cm 125deg (71675541) 10mm Intertan Long Nail Right (2m Bow) 34cm 125D (81050580) 10mm Intertan Long Nail Left - 36cm 125D (71676511) 10mm Intertan Long Nail Left - 38cm 125D (71675225) Intertan 10S Short Nail Universal 10mm x 20cm 125deg (71675385) Intertan 10S Long Nail Right 10mm x 30cm 125deg (71675527) 11.5mm Intertan Long Nail Right (2m Bow) 36cm 125D (81050537) 10mm Intertan Long Nail Right - 36cm 125D (71675224) 10mm Intertan Long Nail Left (1.5m Bow) - 34cm 125D (81087334) 11.5mm x 38cm Intertan Long Nail Right - (1.5 Bow) 125D (81087341) 11.5 mm Intertan Short Nail Universal - 20cm 130D (71675211) Intertan 10S Long Nail Left 10mm x 30cm 125 deg (71675505) INTERTAN 1.5 10MM X 34CM 125D LEFT (71676509) INTERTAN 1.5 1 1.5MM X 36CM 125D RIGHT (71676556) Intertan 10S Long Nail Left 10mm x 26cm 125 deg (71675501) 11.5mm Intertan Long Nail Right (2m Bow) 40cm 125D (81050545) 10mm Intertan Long Nail Right - 34cm 125D (71675222) INTERTAN 1.5 10MM X 38CM 125D RIGHT (71676514) INTERTAN 11.5MM X 36CM 125D LEFT (71675245) 11.5mm Intertan Long Nail Right (1.5m Bow) - 36cm 125D (81087368) 11.5mm Intertan Long Nail Right - 38cm 130D (71675292) 10mm Intertan Short Nail Universal - 18cm 130D (71675207) INTERTAN 11.5MM X 38CM 130D LEFT (71675291) Intertan 10S Long Nail Left 10mm x 46cm 125deg (71675521) Intertan 10S Long Nail Left 10mm x 40cm 125deg (71675515) Intertan 10S Long Nail Left 10mm x 28cm 130 deg (71675504) Intertan 10S Long Nail Right 10mm x 42cm 130deg (71675540) Intertan 10S Long Nail Left 10mm x 44cm 125deg (71675519) Intertan 10S Long Nail Right 10mm x 40cm 125deg (71675537) Intertan 10S Long Nail Left 10mm x 36cm 125deg (71675511) Intertan 10S Long Nail Right 10mm x 26cm 130deg (71675524) Intertan 10S Short Nail Universal 10mm x 18cm 130 degree (81107348) Intertan 10S Long Nail Right 10mm x 46cm 125 degree (81107346) INTERTAN 11.5MM X 40CM 125D RIGHT (71675250) 11.5mm Intertan Long Nail Left (2m Bow) 34cm 130D (81047299) 11.5mm Intertan Long Nail Right (2m Bow) 34cm 125D (81050533) 10mm Intertan Long Nail Left (2m Bow) 40cm 125D (81050526) INTERTAN 11.5MM X 36CM 130D RIGHT (71675290) 10mm Intertan Short Nail Universal - 20cm 125D (81051238, 71675204) INTERTAN 11.5MM X 34CM 130D LEFT (71675287) 11.5mm Intertan Long Nail Left (1.5m Bow) - 38cm 125D (81087340) 10mm Intertan Short Nail Universal (20cm) 130D (81051245) Intertan 10S Short Nail Universal 10mm x 18cm 125Deg (81107347) 10mm Intertan Long Nail Right (1.5m Bow) 36cm 125D (71676512) 10mm Intertan Long Nail Left (2m Bow) 38cm 130D (81047294) Intertan 10S Short Nail Universal 10mm x 18cm 130Deg (81107348) 11.5mm Intertan Short Nail Universal (18cm) 130D (81047293) 10mm Intertan Long Nail Left (2m Bow) 38cm 125D (81050523) 11.5mm Intertan Long Nail Left - 40cm 130D (71675293) 10mm Intertan Long Nail Left - 36cm 130D (71675267) 10mm Intertan Long Nail Left (2m Bow) 34cm 125D (81050487) 10mm Intertan Long Nail Right - 40cm 130D (71675272) INTERTAN 11.5MM X 36CM 125D RIGHT (71675246) Intertan 10S Short Nail Universal 10mm x 18cm 125 degree (81107347) Intertan 10S Long Nail Right 10mm x 40cm 130deg (71675538) Intertan 10S Long Nail Left 10mm x 32cm 125deg (71675507) Intertan 10S Long Nail Left 10mm x 46cm 130deg (71675522) 11.5mm Intertan Long Nail Right (2m Bow) 40cm 130D (81047305) 10mm Intertan Long Nail Right (2m Bow) 34cm 130D (81050581) 10mm Intertan Long Nail Left (2m Bow) 36cm 130D (81050520) INTERTAN 10MM X 40CM 125D LEFT (71675227) 10mm Intertan Long Nail Right (2m Bow) 38cm 130D (81047295) 10mm Intertan Long Nail Left (2m Bow) 34cm 130D (81050490) 10mm Intertan Long Nail Left (2m ow) 36cm 125D (81050517) 11.5mm Intertan Short Nail Universal - 18cm 125D (71675202) 11.5mm Intertan Long Nail Right - 38cm 125D (71676558) Intertan 10S Long Nail Left 10mm x 44cm 130deg (71675520) 11.5mm Intertan Long Nail Left (2m Bow) 40cm 130D (81047304) 11.5mm Intertan Long Nail Right (2m Bow) 38cm 130D (81050542) 10mm Intertan Long Nail Right - 36cm 130D (71675268) 10mm Intertan Long Nail Left - 34cm 125D (71675221) 11.5mm Intertan Long Nail Left - 38cm 125D (71675247) Intertan 10S Long Nail Right 10mm x 46cm 130 degree (81107547) Intertan 10S Long Nail Right 10mm x 26cm 125deg (71675523) Intertan 10S Long Nail Right 10mm x 44cm 130deg (71675542) Intertan 10S Long Nail Left 10mm x 42cm 125deg (71675517) 10mm Intertan Long Nail Right (2m Bow) 36cm 130D (81050585) 10mm Intertan Long Nail Left (1.5m Bow) - 38cm 125D (81087337) 10mm Intertan Long Nail Left - 32cm 130D (71675263) 11.5mm Intertan Long Nail Left (2m Bow) 36cm 125D (81050640) 10mm Intertan Long Nail Right - 38cm 130D (71675270) 10mm Intertan Long Nail Left (2m Bow) 40cm 130D (81047296) 11.5mm Intertan Long Nail Left (2m Bow) 40cm 125D (81050646) 11.5mm Intertan Long Nail Left (2m Bow) 34cm 125D (81050637) 10mm Intertan Long Nail Right (1.5m Bow) - 34cm 125D (81087362) INTERTAN 1.5 11.5MM X 38CM 125D LEFT (71676557) 11.5mm Intertan Short Nail Universal - 18cm 130D (71675208) 10mmx 38cm Intertan Long Nail Right (1.5 Bow) 125D (81087338) 10mm Intertan Long Nail Right (2m Bow) 38cm 125D (81050589) 10mm Intertan Long Nail Left - 34cm 130D (71675265) Intertan 10S Long Nail Right 10mm x 30cm 130deg (71675528) Intertan 10S Long Nail Left 10mm x 42cm 130deg (71675518) INTERTAN 10MM X 40CM 125D RIGHT (71675228) INTERTAN 1.5 10MM X 34CM 125D RIGHT (71676510) INTERTAN 11.5MM X 40CM 125D LEFT (71675249) INTERTAN 10MM X 40CM 130D LEFT (71675271) Intertan 10S Long Nail Right 10mm x 38cm 130deg (71675536) Intertan 10S Short Nail Universal 10mm x 20cm 130 deg (71675386) Intertan 10S Long Nail Right 10mm x 36cm 130deg (71675534) 10mm Intertan Long Nail Left (2m Bow) 32cm 130D (81050483) 10mm Intertan Long Nail Right (2m Bow) 32cm 130D (81050577) Intertan 10S Long Nail Left 10mm x 36cm 130deg (71675512) Intertan 10S Long Nail Right 10mm x 34cm 125deg (71675531) Intertan 10S Long Nail Left 10mm x 34cm 130deg (71675510) Intertan 10S Long Nail Right 10mm x 34cm 130deg (71675532) Intertan 10S Long Nail Left 10mm x 28cm 125 deg (71675503) 10mm Intertan Long Nail Right (2m Bow) 40cm 130D (81047297) 11.5mm Intertan Long Nail Right (2m Bow) 38cm 125D (81050540) 10mm Intertan Short Nail Universal - 20cm 130D (71675210) 10mm Intertan Long Nail Right - 34cm 130D (71675266) Intertan 10S Long Nail Right 10mm x 28cm 130deg (71675526) Intertan 10S Long Nail Right 10mm x 38cm 125deg (71675535) Intertan 10S Long Nail Left 10mm x 38cm 125deg (71675513) Intertan 10S Long Nail Left 10mm x 34cm 125deg (71675509) 11.5mm Intertan Long Nail Right (2m Bow) 36cm 130D (81047302) 11.5mm Intertan Short Nail Universal (18cm) 125D (81051236) INTERTAN 10MM X 38CM 125D RIGHT (71675226) INTERTAN 10MM X 18CM 125D (71675201) Intertan 10S Long Nail Right 10mm x 42cm 125deg (71675539) Intertan 10S Long Nail Right 10mm x 36cm 125deg (71675533) Intertan 10S Long Nail Left 10mm x 40cm 130deg (71675516) Intertan 10S Long Nail Left 10mm x 26cm 130deg (71675551) 71675383 (Intertan 10S Short Nail Universal 10mm x 18cm 125 Deg)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)