BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Glenosphere Trial, 32mm, Offset LAT (1230-4223-002)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    37
    Establishment Types
    1
    Classifications
    2

    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
    K202611

    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
    Shoulder Prosthesis, Reverse Configuration PHX
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD

    Proprietary Names

    Glenosphere Trial, 32mm, Offset LAT (1230-4223-002) Trial Spacer +8 (1230-4258) Reamer Guide Plate 41mm (1230-4289) Glenosphere Inserter (1230-4226) Glenosphere Trial, 40mm, Offset STD (1230-4225-001) Glenosphere Trial, 32mm, Offset STD (1230-4223-001) Humeral Center Guide (1230-4202) Twist Stem Handle ASM (1230-5214) Humeral Drill Guide Size 35 (1230-4241-001) 1230-4314 Humeral Assembly Block Poly Insert Trial, 36mm, Offset +4 (1230-4212-002) Baseplate Inserter (1230-5202) Morse Taper Disassembly Tool (1230-4253) Poly Insert Trial, 32mm, Offset +4 (1230-4211-002) Glenoid Implant Impactor (1230-4243) Small Driver T20 Power (1230-4264) Humeral Head Protector (1230-4203) Reamer Guide Plate 36mm (1230-4286) Humeral Drill ASM (1230-5213) Poly Insert Trial, 36mm, Offset +0 (1230-4212-001) Humeral Implant Impactor (1230-4214) Glenosphere Trial, 40mm, Offset LAT (1230-4225-002) Large Driver T30 (1230-4227) Poly Insert Trial, 40mm, Offset +0 (1230-4213-001) Glenosphere Trial, 36mm, Offset STD (1230-4224-001) Humeral Drill Guide Size 41 (1230-4241-002) 3.2mm Pin (1230-4292) Version Alignment Pin (1230-4259) Humeral Reamer Drive Shaft Assembly (1230-5208) Small Driver T20 (1230-4222) Extrameduallary Cut Guide (1230-4201) Glenosphere Trial, 36mm, Offset LAT (1230-4224-002) Poly Insert Trial, 40mm, Offset +4 (1230-4213-002) Over Baseplate Reamer, ASM (1230-5211) Peripheral Drill Guide ASM (1230-5207) Poly Insert Trial, 32mm, Offset +0 (1230-4211-001) Glenoid Central Drill Guide (1230-5206)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)