FDA Registration Active 🇲🇾 Malaysia

Odyssey Sulcus Cut Guide Size 1

Reg #: 3004889950 · FEI: 3004889950 · Expires 2025
Products
1
Proprietary Names
184
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

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
Guide, Surgical, Instrument FZX

Proprietary Names

Odyssey Sulcus Cut Guide Size 1 Odyssey DCF Valgus Align Guide W/Anterior Clearance EVOLUTION® PROXIMAL TIBIA RIGHT CROSSHEAD (E220100R) NEXGEN PAT PEG DRILL GDE SZ 26 Odyssey MIS Tib Stylus W/Reduced Tip Guide Wire Odyssey Sulcus Cut Guide Size 2 EVOLUTION® PROXIMAL TIBIA LEFT CROSSHEAD (E220100L) Odyssey Sulcus Cut Guide Size 5 Mis Broach Align Guide Rod (20070056) ODYSSEY® 3DG TIB GUIDE RIGHT MORE UNIVERSAL DRILL GUIDE,BONE SCREW (803-05-005) Evolution Proximal Tibia (TAB) Left Crosshead Perfecta Universal EVOLUTION® CEMENT FREE KEEL TOWER SPIKED PIN CLEAR SZ 1-2 (E2004312) ADVANCE® INTRAMEDULLARY ALIGNMENT GUIDE Odyssey DCF Valgus Align Guide Spacer 7mm EVOLUTION® REVISON 4 IN 1 VALGUS BUSHING (E1100310) EVOLUTION®DCF 4 IN 1 RSCT GUID ADJUSTABLE SIZE 1 Evolution Proximal Tibia (TAB) Right Crosshead EVOLUTION® EM TIBIA PROX ROD NON SPIKED SHORT (E2102005) ADVANCE® REPLACEMENT EM SPIKE COMPONENT (K0040110) EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK ADJUSTABLE SIZE 3 (E1204403) EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK ADJUSTABLE SIZE 7 (E1204407) 4mm RSP BASEPLATE DRILL & LOCKING SCREW GUIDE (804-03-048) EVOLUTION® DISTAL FEMORAL ALIGNMENT GUIDE DCF (E1101001) ADVANCE STATURE® SULCUS CUT GUIDE SIZE 3 NARROW (K0014458) ANTERIOR NECK CUTTING GUIDE (20162015) EVOLUTION® ARC QUICK CONNECT (E1102005) EVOLUTION® ARC RESECTION GUIDE (E1202001) DRILL GUIDE, 2.5MM X 15DG ANGLE (804-03-036) Empowr 3D Knee™ 4-In-1 Cut Blocks,2 - Size 10 (800-05-091) Empowr 3D Knee™ 4-In-1 Cut Blocks,2 - Size 4 (800-05-084) EVOLUTION®DCF 4IN 1 RSCT GUIDE ADJUSTABLE SIZE 5 (E1204105) EVOLUTION® MA DCF POS REF 4IN1 RSCT BLCK ADJUSTABLE SIZE 6 (E1204406) EVOLUTION®DCF 4 IN 1 RSCT GUID ADJUSTABLE SIZE 7 (E1204107) ADVANCE STATURE® SULCUS CUT GUIDE SIZE 2 NARROW (K0014457) Empowr 3D Knee™ 4-In-1 Cut Blocks,2 - Size 6 (800-05-086) ODYSSEY® DCF FEM RESECT BLOCK W/ WIDE ANT SLOT SZ 5 (K0014385) Empowr 3D Knee™ 4-In-1 Cut Blocks,2 - Size 7 (800-05-087) EVOLUTION®CS / CR SULCUS GUIDE RESECTION SZ 2 (E1201002) Empowr 3D Knee™ 4-In-1 Cut Blocks,2 - Size 2 (800-05-082) ODYSSEY® DCF FEM RESECT BLOCK W/ WIDE ANT SLOT SZ 3 (K0014383) Empowr 3D Knee™ 4-In-1 Cut Blocks,2 - Size 5 (800-05-085) Empowr Porous Knee™ Locking Tibial Punch Guide (80105205) EVOLUTION® REV CUT THRU CCK, BOX CUT GUIDE SIZE 6 (E1205306) ADVANCE® PATELLA REAMER 1 HOLE DRILL GUIDE (K0031109) PROFEMUR® NECK RESECTION GUIDE (PTRG0410) EVOLUTION®DCF 4IN 1 RSCT GUIDE ADJUSTABLE SIZE 4 (E1204104) Empowr 3D Knee™ 4-In-1 Cut Blocks,2 - Size 8 (800-05-088) GLENOID HEAD TRIAL, 40MM/NEU, GREEN, TI (80403046) EVOLUTION®DCF 4IN 1 RSCT GUIDE ADJUSTABLE SIZE 3 (E1204103) VALOR® NAIL 3MM BEADED K-WIR (4150004030) Empowr 3D Knee™ 4-In-1 Cut Blocks,2 - Size 3 (800-05-083) Linear Hip Instrument, Standard, Neck Trial (80303055) ADVANCE STATURE® SULCUS CUT GUIDE SIZE 4 NARROW (K0014459) ODYSSEY® SULCUS CUT GUIDE SIZE 4 (K0014454) DJO Empowr Knee™ Tibial Augment Cut Guide, RM/LL (80105055) ADVANCE® ALL POLY PATELLAR ENDMILL GUIDE TRI-PEG (K0031002) EVOLUTION® REV CUT THRU CCK, BOX CUT GUIDE SIZE 8 (E1205308) Wire Guide 1.4mm x 145mm Sterile Mica Screw System (57S10314) EVOLUTION® PATELLA 3 HOLE DRILL GUIDE NON SYMMETRIC (E4201103) Empowr Knee Femoral Preparation Guide, 10mm (80006040) Linear Hip Instrument, Lateral, Neck Trial (80303056) Empowr Knee Femoral Preparation Guide, 9mm (80006039) Wire Guide 0.9mm x 145mm Sterile Mica Screw System (57S10309) DJO Empowr Knee™ Tibial 3 Deg Slope Resection Guide 3, Right (80105077) EVOLUTION®DCF 4IN 1 RSCT GUIDE ADJUSTABLE SIZE 6 (E1204106) EVOLUTION® REV CUT THRU BUSH, ADAPTER CCK SIZE 3-6 RIGHT (E630346R) EVOLUTION® REV CUT THRU BUSH, ADAPTER CCK SIZE 7-8 RIGHT (E630078R) RSP Trial, Socket, +4mm (804-02-058) DJO Empowr Knee™ Stem Trial, 14mm x 40mm (801-05-063) GLENOID HEAD TRIAL,32MM/NEU, BLUE TI (80403042) GLENOID HEAD TRIAL, 36MM/NEU, YELLOW TI (80403044) Handle,Drill Guide, W / Spring Pin (804-25-040) Empowr Knee Femoral Preparation Guide, 8mm (80006038) EVOLUTION® REV CUT THRU CCK, BOX CUT GUIDE SIZE 5 (E1205305) DJO Empowr Knee™ Cemented Stemmable Tibial Punch, Small (801-05-049) DJO Empowr Knee™ Tibial 3 Deg Slope Resection Guide 3, Left (80105076) INS, KNEE, EMPOWR, Tib Resection Guide, Slotted, LM-RL, LL REV CHANGE COMING - 80106005 INS, KNEE, EMPOWR, Tib Resection Guide, Slotted, RM-LL, LL REV CHANGE COMING - 80106004 Tibial Base Trial, Exprt, Sz A (801-01-734) DJO Empowr Knee™ Tibial Augment Cut Guide, LM/RL (80105056) DJO Empowr Knee™ Tibial Resection Guide 3, Right (80105075) Size XX Patella Sizer/Drill Guide (80201033) DJO Empowr Knee™ Tibial Resection Guide 3, Left (80105074) RSP Trial, Socket, +8mm (804-02-059) FMP Acetabular Impactor Alignment Guide, Lateral (803-05-338) Empowr Partial Knee Tibial Peg Drill Guide (801-06-074) INS, KNEE, EMPOWR, Tib Resection Guide, Open Face, LM-RL, LL - 80106003 DJO Empowr Knee™ Stem Trial, 12mm x 65mm (801-05-062) DJO Empowr Knee™ Adjustable Femoral Sizer (800-05-038) EVOLUTION® REV CUT THRU BUSH, ADAPTER CCK SIZE 7-8 LEFT (E630078L) DJO Empowr Knee™ Stem Trial, 10mm x 40mm (801-05-059) DJO Empowr Knee™ Adjustable Femoral Stylus (800-05-037) EVOLUTION® REV CUT THRU CCK, BOX CUT GUIDE SIZE 4 (E1205304) DJO Empowr Knee™ 2Deg Post Slope Recut Guide (801-05-021) DJO Empowr Knee, Femoral Sizer2, Mach (80005034) DJO Empowr Knee™ Tibial Outrigger Cut Guide Adapter (80105058) Evolution® Patella 1 Hole Drill Guide Non Symmetric (E4201101) Guide Wire, 2.5mm x 250mm (W1100-0250) DJO Empowr Knee™ +2 mm Recut Guide (801-05-023) INS, KNEE, EMPOWR, Tib Resection Guide, Open Face, RM-LL, LL - 80106002 Glenoid Head Trial, 44+8mm (804-04-048) Inst Cut Gde Body Foot SS Mcm (156187) ALTIVATE REVERSE, HEMI ADAPTER TRIAL, TURON (804-06-220) KWIRE GUIDE 1.4MM (D0314C2N) DJO Empowr Knee™ Stem Trials, 12mm x 40mm (801-05-061) TARGET GUIDE (57700001) Humeral Socket Liner Trial, 36 +4 Semi (804-02-463) Empowr PS Knee™ Condyle Captured Box Guide Sizes 2 (800-05-069) Humeral Socket Liner Trial, 40 +4 Semi (804-02-465) All in One Cut Block, Size 3 (800-05-133) Empowr PS Knee™ Condyle Captured Box Guide Sizes 3 (800-05-070) Inst Cut Gde Paddle Foot SS Mcm (156188) DJO Empowr Knee™ 2 Deg Varus Valgus Recut Guide (801-05-022) Tibial Base Trial, Exprt, Sz C (801-01-736) DJO Empowr Knee™ Stem Trial, 10mm x 65mm (801-05-060) Depth Gage, Primary Acet (803-15-015) Empowr Partial Knee™ Distal Femoral Resection Guide, +1mm Offset (800-06-035) Tibial Base Trial, Exprt, Sz B (801-01-735) Humeral Socket Liner Trial, 40 +4 Std (804-02-464) Humeral Socket Liner Trial, 32 +4 Semi (804-02-461) DJO Empowr Knee™ Stem Trial, 14mm x 65mm (801-05-064) Guide Wire, 1.4mm x 150mm (W1100-0140) Drill Guide, Bowed, 10mm Collar (803-15-014) All in One Cut Block, Size 5 (800-05-135) EXPRT™ Tibial Base Trial, Size D (801-01-737) 1.4MM Guide Wire (CSS-040-14) All in One Cut Block, Size 2 (800-05-132) Tapered Stem Trial, Exprt, 65mm (801-01-741) All in One Cut Block, Size 8 (800-05-138) All in One Cut Block, Size 10 (800-05-140) Empowr Partial Knee™ Distal Femoral Resection Guide, Std Offset (800-06-034) 1456-7700 Screw Guide Humeral Socket Liner Trial, 32 +4 Std (804-02-460) Humeral Socket Liner Trial, 36 +4 Std (804-02-462) Empowr Partial Knee™ Distal Femoral Resection Guide, -1mm Offset (800-06-036) LISFRANC NON LOCKING DRILL GUIDE CHARLOTTE™ F&A SYSTEM (43510050) Drill Bit Guide 4.9mm (D0349C2N) All in One Cut Block, Size 4 (800-05-134) Drill Bit Guide 3.3mm (D0333C2N) All in One Cut Block, Size 11 (800-05-141) Acetabular Alignment Clip, 40deg X 20deg, Supine (803-15-037) Altivate Anatomic AG, Half Wedge Reaming Guide, 7mm, Left (804-09-028) Drill Bit Guide 5.3mm (D0353C2N) Drill Bit Guide 3.9mm (D0339C2N) Lisfranc Blunt Trocar Wright™ Lisfranc System (43510120) All in One Cut Block, Size 7 (800-05-137) (156173) Locking Drill Guide 2.8mm Altivate Anatomic AG, Half Wedge Reaming Guide, 5mm, Right (804-09-027) All in One Cut Block, Size 9 (800-05-139) Comp Drl Slv Extl 3mm Foot Raptor™ Staple System (156277) (156172) Locking Drill Guide 2mm Altivate Anatomic AG, Half Wedge Reaming Guide, 5mm, Left (804-09-026) Empowr Knee Offset Patella Drill Guide, Large (802-05-107) COMP DRL GDE SLV 2.8MM (156031) AEQUALIS HUM NAIL SHARP GUIDE WIRE (9020035) Acetabular Alignment Clip, 40deg X 20deg, Lateral (803-15-036) Altivate Anatomic AG, Half Wedge Reaming Guide, 7mm, Right (804-09-029) Comp Drl Slv Intrl 3mm Foot FuseForce™ Flex Staple System (156265) 3 x 75 mm Guide Pin (9722908) Acetabular Alignment Rod (803-15-005) Altivate Reverse, Hemi-Adapter Trial, Anatomic, Stem, Neutral (804-06-216) 804-06-222 (Altivate Reverse, Hemi-adapter Trial, Anatomic, Broach, Off) Comp Lckr Drl Gde Slv 2.8mm (156173) Glenoid Head Inserter/ Impactor (804-03-051) 804-06-221 (Altivate Reverse, Hemi-adapter Trial, Anatomic, Broach, Neut) 804-06-223 (Altivate Reverse, Small Hemi-adapter Trial, Anatomic, 38X14) C Ring (881-1-10002-02) SPECIAL, RSP CENTRAL DRILL GUIDE, 0° TILT (S-201244) Guide Pin 440mm, SFP (Sterile) (881-1-10010A) CSS-040-14 Maxtorque 1.4mm Guide Wire 804-06-224 (Altivate Reverse, Small Hemi-adapter Trial, Anatomic, 40X14) Honeycomb (881-1-10002-01) TRIGEN MAX 3.2MM X 360MM THREAD TIP GUIDE PIN (81122681) Guide Pin 440mm, SFP (881-1-10010A) EMPOWR REVISION KNEE™ ANTERIOR BOX RESECTION GUIDE, SIZE 6-11 (800-05-097) TRIGEN MAX 3MM X 900MM BALL TIPPED GUIDE ROD (81122679) RSP BASEPLATE DRILL & LOCKING SCREW GUIDE - REDUCED PROFILE FACE (S-200698) SPECIAL, SHORTENED RSP BASEPLATE DRILL/SCREW GUIDE (S-201106) Multi-Hole Trocar Drill Sleeve (881-1-10002) RSP 3 BARREL DRILL GUIDE (S-200860) TRIGEN MAX 3.2MM X 360MM DRILL TIP GUIDE PIN (81122680)

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)