BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    ALTIVATE REVERSE, HUMERAL CANAL REAMER, SIZE 18 (804-06-028)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    91
    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
    Reamer HTO

    Proprietary Names

    ALTIVATE REVERSE, HUMERAL CANAL REAMER, SIZE 18 (804-06-028) AltiVate Anatomic, Cannulated Glenoid Reamer, Size 54 (804-07-154) AltiVate Anatomic, Non-Cannulated Glenoid Reamer, Size 42 (804-07-242) AltiVate Anatomic, Cannulated Glenoid Reamer, Size 42 (804-07-142) ALTIVATE REVERSE, HUMERAL CANAL REAMER, SIZE 6 (804-06-016) AltiVate Anatomic, Cannulated Glenoid Reamer, Size 50 (804-07-150) ALTIVATE REVERSE, HUMERAL CANAL REAMER, SIZE 10 (804-06-020) AltiVate Anatomic, Non-Cannulated Glenoid Reamer, Size 46 (804-07-246) DJO EMPOWR KNEETM STEM REAMER, 11MM (801-05-046) Sapphire Nail System-Step Reamer Advance Patella Reamer Surgical Humeral Starter Reamer (80400002) ADVANCE® PRESS FIT REAMER SLEEVE (K0027104) 57S0L122 Drill Bit 2.2mm Solid Long Sterile Mica REAMER, GLENOID LARGE RSP SHOULDER (80403015) ADVANCE® DRIVER HANDLE THREADED W/ CHAMFER (K0001112) 57SC320L Mica Cutting Burr 3 x 20mm Long Mica REAMER, GLENOID SMALL RSP SHOULDER (80403013) REAMER, STARTER GLENOID RSP SHOULDER (80403012) Wedge Burr 4.1 x 13mm Sterile Mica (57SW4113) EVOLUTION® REV SP REAMER, 18MM (E2431018) 57SW3113 Wedge Burr 3.1 x 13mm Sterile Mica Evolution Reamer Sleeve (E2005079) COMP CANN RMR 7.5MM (154964) REAMER, GLENOID MEDIUM RSP SHOULDER (80403014) DJO Empowr Knee™ Tibial Reamer Locator, Neutral (80105054) Hinge Inst Trunion Over Reamer (94060296) RSP Glenoid Reamer Driver (804-03-011) Exprt Revision Hip, Distal Reamer, 19mm (803-95-019) Exprt Revision Hip, Distal Reamer 15mm (803-95-015) Augment Reamer (1230-5205) Exprt Revision Hip, Distal Reamer, 27mm (803-95-027) Exprt Revision Hip, Distal Reamer, 16mm (803-95-016) Exprt Revision Hip, Distal Reamer, 28mm (803-95-028) DJO Empowr Knee™ Tibial IM Proximal Body - Stem Reamer (801-05-079) Exprt Revision Hip, Distal Reamer, 17mm (803-95-017) Exprt Revision Hip, Distal Reamer, 13mm (803-95-013) Special Exprt Revision Hip Proximal Reamer, Long (S201418) COMP HD RMR 20MM (156130) Special Exprt Revision Hip Distal Reamer, 12mm, Cannulated (S201417) Exprt Revision Hip, Proximal Reamer (803-95-005) COMP CUP RMR 22MM (156139) Glenoid Reamer (1230-5204) Reamer Head Asm, 36mm (1230-5209-001) Exprt Revision Hip, Distal Reamer, 26mm (803-95-026) Exprt Revision Hip, Distal Reamer, 20mm (803-95-020) Exprt Revision Hip, Distal Reamer, 25mm (803-95-025) COMP CUP RMR 20MM (156138) Exprt Revision Hip, Distal Reamer, 21mm (803-95-021) COMP HD RMR 22MM (156131) COMP HD RMR 16MM (156128) Altivate Anatomic™ Humeral Canal Reamer, 18mm (804-07-018) Exprt Revision Hip, Distal Reamer, 12mm (803-95-012) Exprt Revision Hip, Distal Reamer, 22mm (803-95-022) Exprt Revision Hip, Distal Reamer, 23mm (803-95-023) Exprt Revision Hip, Distal Reamer, 14mm (803-95-014) Reamer Head Asm, 41mm (1230-5209-002) Exprt Revision Hip, Distal Reamer, 24mm (803-95-024) COMP HD RMR 18MM (156129) P672-20-16 Reamer, Methead QC 20mm/1.6mm COMP CUP RMR 18MM (156137) COMP CUP RMR 16MM (156136) P672-14-16 Reamer,Methead QC 14mm/1.6mm Reamer, Phalanx QC 18mm/1.6mm (P682-18-16) Reamer, Phalanx QC 14mm/1.6mm (P682-14-16) P672-18-16 Reamer, Methead QC 18mm/1.6mm Reamer, Phalanx QC 20mm/1.6mm (P682-20-16) 62“ x 3” Olive Wire, Arsenal Ankle (340-60-005) Lag Screw Reamer, SFP (880-1-10220) 282-1-10016 (Entry Reamer, SFP) 414853-001 (ULNA REAMER 5MM) 414855-001 (ULNA REAMER 7MM) ALTIVATE REVERSE, HUMERAL CANAL REAMER, SIZE 12 (804-06-022) ALTIVATE REVERSE, HUMERAL CANAL REAMER, SIZE 20 (804-06-030) AltiVate Anatomic, Cannulated Glenoid Reamer, Size 38 (804-07-138) AltiVate Anatomic, Non-Cannulated Glenoid Reamer, Size 38 (804-07-238) ALTIVATE REVERSE, HUMERAL CANAL REAMER, SIZE 8 (804-06-018) 414854-001 (ULNA REAMER 6MM) ALTIVATE REVERSE, HUMERAL CANAL REAMER, SIZE 16 (804-06-026) Reamer, Phalanx QC 16mm/1.6mm (P682-16-16) P672-22-16 Reamer,Methead QC 22mm/1.6mm P672-16-16 Reamer,Methead QC16mm/1.6mm ALTIVATE REVERSE, HUMERAL CANAL REAMER, SIZE 14 (804-06-024) Reamer, Phalanx 22mm w/1.6mm cann (P682-22-16) 881-1-10021 (16mm Channel Reamer, SFP) 062“ x 3” Olive Wire Partially Threaded (330-60-005) AltiVate Anatomic, Non-Cannulated Glenoid Reamer, Size 50 (804-07-250) DJO EMPOWR KNEETM Tibial Stem Reamer (801-05-043) AltiVate Anatomic, Non-Cannulated Glenoid Reamer, Size 54 (804-07-254) AltiVate Anatomic, Cannulated Glenoid Reamer, Size 46 (804-07-146) ALTIVATE REVERSE, HUMERAL CANAL REAMER, SIZE 5 (804-06-015)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)