BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    PATH® REAMER SHAFT (20070011)

    Reg #: 3012217062 · FEI: 3012217062 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    88
    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
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE

    Proprietary Names

    PATH® REAMER SHAFT (20070011) ADVANCE® INTRAMEDULLARY REAMER 17.5mm (K0050517) ADVANCE® INTRAMEDULLARY REAMER 19.5mm (K0050519) ADVANCE® INTRAMEDULLARY REAMER 20.5mm (K0050520) PERFECTA® POWER CALCAR PLANER LARGE (4700CP0000) K-Wire 0.9 x 150mm Blunt/Trocar (Tab) (DSDS1009S) K-Wire 1.4 x 150mm Blunt/Trocar (Tab) (138596) SMH01524 SPECIAL EXTENDED LENGTH PATH® REAMER SHAFT K-Wire 1.4 x 150mm Blunt/Trocar (Tab) (DSDS1014S) PROFEMUR® TAP METAPHYSEAL REAM (PTMR0001) INITIAL CANAL REAMER RASP SIZE 10(PPW36302) SMH01521 SPECIAL EXTENDED LENGTH SUPERPATH® SCREW DRILL TUBE Inst K-Wire 1.6 x 100mm SS ProStep™ Tailor's Bunion (154490) K-WIRE 1.1 X 150MM SS NONSTERILE DBL TROCAR IMPLANTABLE - 45750001 K-Wire 1.1 x 150mm Blunt/Trocar (Tab) (DSDS1011S) K-WIRE 1.4MM X 228MM - 500036 DARCO®HEADED 2.5MM K-WIRE QTY1 - 707092502 EVOLUTION# REVISON REAMER 16.5MM K-Wire 0.9 x 150mm Blunt/Trocar (Tab) 138594 K-WIRE 1.4MM - 24872018 K-Wire 0.9 x 70mm Blunt / Trocar (94057776, DHVS1009) EVOLUTION® CEMENTED REAMER SIZE 2+ - 8+ (E2001238) DARCO® HEADED 3MM K-WIRE QTY 1 270MM LONG SMOOTH TIP - 707093002 VALOR® NAIL 3MM K-WIRE - 4150004025 K-WIRE 1.4 X150MM BLUNT/TROCAR - DSDS1014 INST WIRE 0.9MM FOOT SS MCM (156163) EVOLUTION# REVISION REAMER 25MM (E2431002) K-Wire 1.1 x 150mm Blunt/Trocar (Tab) (138595) PROFEMUR® FEMORAL REAMER SIZE 8 (PRR00080) EVOLUTION® CEMENT FREE REAMER SIZE 1 - 2 (E2001112) PERFECTA® FEMORAL REAMER 9mm (4700R09000) EVOLUTION® CEMENT FREE REAMER SIZE 2+ - 8+ (E2001138) K-WIRE 0.9MM X 102MM (45302001) PROFEMUR® PRESERVE CANAL FINDER (20070186) EVOLUTION® 3.5MM HEX DRIVER (E5001005) K-WIRE 0.9 X150MM BLUNT/TROCAR - DSDS1009 ADVANCE® INTRAMEDULLARY REAMER 20mm (K0051020) DARCO®HEADED 2.5MM K-WIRE QTY1 - 707092503 SINGLE TROCAR WIRE 1X150MM - 44112000 K-WIRE 1.4MM X 102MM Phalinx Hammertoe - 45302003 2.4 x 230mm K-wire (155963) PRO-TOE® VO 1.1MM K-WIRE - 45719011 SINGLE TROCAR WIRE 1.6X150MM - 44112008 1.4 x 150mm K-wire (155960) INBONE® STEINMANN PIN, 2.4MM - 200072 K-WIRE 1MM X 100MM - NO2228210 JONES K-WIRE 228MM - 56010228 K-WIRE 1.1 X150MM BLUNT/TROCAR - DSDS1011 K-WIRE 0.9MM X 100MM (NO2228209) K-WIRE 0.9 X 150MM - 707090002 K-WIRE 2.5MM X 230MM NO THREAD CHARLOTTE F&A SYSTEM - 44180230 K-Wire 1.1mm X 102mm Phalinx Hammertoe - 45302002 K-Wire 2 x 150 mm Sterile (D0620150S) K-Wire 2.4 x 230 mm Sterile (D0624230S) K-WIRE 1.2 X 150MM - 707091202 K-WIRE 1.1MM X 140MM - NO2228012 K-WIRE 2.5MM X 230MM THREADED - 44182523 K-Wire 1.4/2mm (56021420) K-WIRE 0.9 X 100MM STERILE (D0609100S) EVOLUTION# REVISON REAMER 16MM (E2431160) COMP K-WIRE 0.9MM X 150MM (154965) K-WIRE 1.4 X 150MM STERILE (D0614150S) K-WIRE, 1.4 x 150MM PHALINX HAMMERTOE (154967) PERFORM PERIPHERAL PLANER SIZE (MWM044) K-WIRE 1 X 100MM STERILE (D0610100S) K-wire 2.4mm x 230 (155963) 0.9 x 150mm K-wire (155957) (156030) Cup Reamer 22mm (156025) Cone Reamer 22mm DARCO® HEADED 3MM K-WIRE (707093003) COMP K-WIRE 1.1MM X 150MM (154966) K-WIRE 2.5MM X 150MM (58862515) SALVATION ™ K WIRE 2.4 X 250 (SMN10017) K-Wire Guide 2mm (D0320C2N) PERFORM PERIPHERAL PLANER SIZE (MWM043) Empowr Knee Patella Drill (802-05-108) PERFORM PERIPHERAL PLANER SIZE (MWM042) (156022) Cone Reamer 16mm (156027) Cup Reamer 16mm Empowr Press Fit Knee™ Patella Over Drill (802-05-104) DJO Empowr Knee™ Stepped Femoral Peg Drill (800-05-079) PERFORM PERIPHERAL PLANER SIZE (MWM041) MICA 2MM TARGETING GUIDE PIN PROSTEP MICA INSTRUMENTS (57790010) 155962 (COMP K-WIRE 2 X 150MM) 57KWPACK (K-Wire Procedure Pack Prostep Mis Lapidus System) 156965 (Inst K-Wire 0.9 X 150mm SS) CALCAR PLANAR, 40MM (803-03-242) Inst K-Wire 1.4 X 150mm SS (156966)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)