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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2015-01-13 |
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)