BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Jet-X Central Hybrid Clamp MR Safe (71051723)

    Reg #: 3004889950 · FEI: 3004889950 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    136
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Straits Orthopaedics (MFG) Sdn Bhd
    Registration Number
    3004889950
    FEI Number
    3004889950
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2, Lengkok Teluk Kumbar 1, Jalan Teluk Kumbar
    City
    Bayan Lepas Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K994143

    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
    Pin, Fixation, Threaded JDW

    Proprietary Names

    Jet-X Central Hybrid Clamp MR Safe (71051723) Jet-X 10.5mm To 5mm Clamp MR Safe (71064001, 71064002) Jet-X Central Hybrid Clamp MR Safe (81015931) 81107262 - Threaded Rod-XXS Full Rings 180mm (81107004) Strut Body Long (1452654) SPATIAL SHOULDER BOLT (71070310) HALF PIN FIXATION BOLT 4MM (100614) Strut Body-XXS 81106572 Small Hinge Pin 81110057 Adjustment Nut 81106490 1450096 Track Pin Set Screw Spatial Frame Foot Ring 155mm Long (81107034) BOLT 16MM (103201) Proximal U-Joint Clevis 81107410 2/3 Ring 205mm (81107018) Steinman Pin Type "B" 9" Long (0.14") (128117) Spatial Frame Foot Ring 155mm Short (81107036) Full Rings 155mm (81107003) 2/3 Ring 180mm (Blue) (81115092) Steinman Pin Type "E" 9" Long (0.14") (128120) Ball Joint Bolt (81016793) Steinman Pin Type "E" 9" Long (0.156") (128130) 2/3 Ring 180mm (Red) (81115113) Full Ring 155mm (Pink) (81115088) Spatial Frame Half Ring 180mm (Pink) (81115103) Spatial Frame Foot Ring 155mm Long (Pink) (81115189) Smart TSF U Ring 130mm Inner Dia (81107040) Steinman Pin Type "D" 9" Long (0.125") (128109) Smart TSF U Ring180mm Inner Dia (81113662) Steinman Pin Type "F" 9" Long (0.14") (128121) Kirschner Wire Diamond Point 2 Ends - 1.1mm Dia x "A" Dim (5") (128040) Steinman Pin Type "F" 9" Long (0.187") (128141) Full Ring 155mm (Red) (81115087) 81107011 Spartial Frame Half Ring 230mm 81107037 Spatial Frame Foot Ring 180mm Short Steinman Pin Type "A" 9" Long (0.187") (128136) 81107014 2/3 Rings 130mm NUT 10MM (103300) Spatial Frame U Plate, 155mm Inner Diameter (81107041) Spatial Frame Half Ring 180mm (Red) (81115102) Large Hinge Pin 81110058 81107007 Spartial Frame Half Ring 130mm Steinman Kirschner Hinge Bushing 81106494 81107005 Full Rings 205mm Spatial Frame Foot Ring 180mm Long (Pink) (81115193) 81107239 DTSF Track Pin Strut Body Washer (81107218) HALF PIN FIXATION BOLT 6MM (100616) Fast FX Strut For TSF, Medium (71070720) Steinman Pin Type "C" 9" Long (0.156") (128128) Spatial Frame Half Ring 155mm (Blue) (81115098) 1.8mm Ilizarov Wire With Olive Xlgre (920388) 1.6mm Dia x 152mm Pediatric Guide Pin (128197) 2/3 Ring 105mm (Pink) (81115167) Strut Body Medium (Fast Fx) (1452651) Spatial Frame Half Ring 155mm (81107008) Steinman Pin Type "B" 9" Long (0.156") (128127) Kirschner Wire Diamond Point Two Ends 62 Dia (7") (128061) HALF PIN FIXATION BOLT 5MM (100615) 2/3 Ring 155mm (Red) (81115112) 2/3 Ring 130mm (Blue) (81115105) Full Ring 180mm (Pink) (81115091) 81107013 2/3 Rings 105mm 2/3 Rings 155mm (81107015) Strut Body Extra Short (Fast Fx) (1404828) 81107016 2/3 Rings 180mm 2/3 Ring 105mm (Red) (81115110) Ring Mount U-Joint Clevis 81106491 Spatial Frame Foot Ring 180mm Long (Red) (81115192) Steinman Pin Type "D" 9" Long (078") (128079) 81107040 Spatial Frame U Plate, 130mm Inner Diameter Steinman Pin Type "D" 9" Long (0.187") (128139) Steinman Pin Type "B" 9" Long (093") (128087) Steinman Pin Type "D" 9" Long (0.156") (128129) Full Ring 130mm (Red) (81115084) Modified 10mm Hex Nut (81049317) Full Ring 130mm (Pink) (81115085) Spatial Frame Half Ring 155mm (Red) (81115099) Spatial Frame Half Ring 180mm (Blue) (81115101) 2/3 Ring 155mm (Pink) (81115169) 3.5mm PF Pin 18mm (71173324) 2/3 Ring 155mm (Blue) (81115106) 81107001 Full Rings 105mm Swanson Finger Wire 35 Dia x 5" Long (128145) Full Ring 105mm (Red) (81115093) Spatial Frame Foot Ring 155mm Long (Red) (81115188) Steinman Pin Type "C" 9" Long (0.109") (128098) Full Ring 130mm (Blue) (81115083) Spatial Frame Shoulder Bolt (71070310) Steinman Pin Type "D" 9" Long (0.109") (128099) Steinman Pin Type "F" 9" Long (0.156") (128131) 2/3 Ring 180mm (Pink) (81115170) 2/3 Ring 130mm (Pink) (81115168) 81107002 Full Rings 130mm Smart Standard Strut XX-Short (71075200) 81107039 Spatial Frame U Plate, 105mm Inner Diameter 81107006 Fulls Ring 230mm 2/3 Ring 130mm (Red) (81115111) Smart TSF U Ring 105mm Inner Dia (81113659) 2/3 Ring 105mm (Blue) (81115104) Smart TSF U Ring, 155mm Inner Diameter (81107041) Full Ring 180mm (Red) (81115090) Full Ring 105mm (Blue) (81115092) Spatial Frame Foot Ring 155mm Long (Blue) (81115186) 81107010 Spartial Frame Half Ring 205mm Fast FX Strut For TSF, Short (71070710) Strut Body Short (1452553) Spatial Frame Foot Ring 180mm Long (Blue) (81115190) Full Ring 180mm (Blue) (81115089) Full Ring 155mm (Blue) (81115086) Full Ring 105mm (Pink) (81115094) Smart TSF U Ring155mm Inner Dia (81113661) Spatial Frame Half Ring 155mm (Pink) (81115100) 81107017 2/3 Rings 205mm 71075244P (Spatial Frame Foot Ring 155mm Long (Purple)) Smart Standard Strut Short (71075210) Smart Standard Strut Medium (71075220) Smart Standard Strut Long (71075230) Smart Standard Strut X-Short (71075205) Shoulder Bolt (81106463) 71075214P (Full Rings 155mm (Purple)) 81116585 (Disposable Tissue Protector/Drill Sleeve with Trocar ) 81116586 (Pin Driver Assembly ) Ilizarov Wire With Stopper, 400mm Length (81126286) 1.8mm Ilizarov Wire, Smooth, Olive and Bayonette Point (81126290) Bolt 10mm (1451137) 1.8mm Ilizarov Wire, Smooth, Bayonette Point (81126288) 1.8mm Ilizarov Wire, Smooth, Olive and Bayonette Point (81056888) Ilizarov Wire With Stopper, 300mm Length (102106) Ilizarov Wire With Stopper, 300mm Length (81126285) 71075224P (Spatial Frame Half Ring 155mm (Purple)) 71075206P (2/3 Rings 155mm (Purple)) 1.8mm Ilizarov Wire, Smooth, Bayonette Point (81056887) Ilizarov Wire With Stopper, 400mm Length (102107)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)