FDA Registration
Active
🇲🇾 Malaysia
Tibial Broach Guide (MO10431M) M-3220-5019
Reg #: 3004889950
·
FEI: 3004889950
·
Expires 2025
Products
1
Proprietary Names
50
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
- K113369
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 |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2015-01-18 |
Proprietary Names
Tibial Broach Guide (MO10431M) M-3220-5019
PS Notch Cutting Jig Size 3 (MO10399M) M-3120-5019
Baseplate Tibial Tray Size 6 (MO10417M) M-3211-0006
Baseplate Tibial Tray Size 1 (MO10412M) M-3211-0001
Gap Gauge insert (MO10423M) M-3220-5007
Calcar Planner (MO10324M)
Femoral Anterior Chamfer Cutting Guide Sz 4 (MO10393M) M-3120-5013
CR Pateller Drill (MO10404M) M-3120-5027
Tibial EM Alignment Guide Spikeless Top Shaft (MO10430M) M-3220-5016
Femoral Anterior Chamfer Cutting Guide Sz 6 (MO10395M) M-3120-5015
Femoral Posterior Chamfer Cutting Guide Size 1 (MO10406M) M-3120-5031
Pin Long (MO10383M) M-3120-5003
Cutting Guide Distal Femoral (MO10386M) M-3120-5006
Tibial Stylus (MO10421M) M-3220-5004
Femoral Anterior Chamfer Cutting Guide Sz 5 (MO10393M) M-3120-5014
Femoral Posterior Chamfer Cutting Guide Size 4 (MO10409M) M-3120-5034
Alignment Guide Distal Femoral (MO10385M) M-3120-5005
PS Notch Cutting Jig Size 5 (MO103401M) M-3120-5021
Stem Extractor (MO10315M)
Rod Femoral IM (MO10381M) M-3120-5001
Femoral Sizer Anterior (MO10388M) M-3120-5008
Three Step Drill (MO10380M) M-3120-5000
Pin Driver (MO10384) M-3120-5004
PS Notch Cutting Jig Size 1 (MO10397M) M-3120-5017
Baseplate Tibial Tray Size 4 (MO10415M) M-3211-0004
Patellar Drill Guide 29mm (MO10433M) M-3420-5002
Tibial Baseplate Trial Handle (MO10427M) M-3220-5011
PS Notch Cutting Jig Size 4 (MO103400M) M-3120-5020
Femoral Anterior Chamfer Cutting Guide Sz 1 (MO10390M) M-3120-5010
Patellar Cement Clamp (MO10434M) M-3420-5003
Dome Impactor Size 1 & 2 (MO10325M - MO10326M)
Blade Gauge (MO10396M) M-3120-5016
Femoral Posterior Chamfer Cutting Guide Size 2 (MO10407M) M-3120-5032
Alignment Guide Femoral IM (MO10382M) M-3120-5002
Femoral Posterior Chamfer Cutting Guide Size 3 (MO10408M) M-3120-5033
Femoral Posterior Chamfer Cutting Guide Size 5 (MO10410M) M-3120-5035
Femoral Posterior Chamfer Cutting Guide Size 6 (MO10411M) M-3120-5036
Baseplate Tibial Tray Size 5 (MO10416M) M-3211-0005
Femoral Size Posterior (MO10389M)
Osteo Cutter, Angled Box (MO10319M)
Baseplate Tibial Tray Size 3 (MO10414M) M-3211-0003
Pin Extractor (MO10387M) M-3120-5007
Head Impactor (MO10317M)
PS Notch Cutting Jig Size 2 (MO10398M) M-3120-5018
Baseplate Tibial Tray Size 2 (MO10413M) M-3211-0002
PS Notch Cutting Jig Size 6 (MO103402M) M-3120-5022
PS Reamer (MO10403M) M-3120-5023
Femoral Anterior Chamfer Cutting Guide Sz 3 (MO10390M) M-3120-5012
Femoral Anterior Chamfer Cutting Guide Sz 2 (MO10391M) M-3120-5011
Headed Pin (MO10429M) M-3220-5015
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)