FDA Registration
Active
🇲🇾 Malaysia
Stem Impactor
Reg #: 3008840738
·
FEI: 3008840738
·
Expires 2025
Products
1
Proprietary Names
75
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HAMAGAWA INDUSTRIAL M SDN BHD
- Registration Number
- 3008840738
- FEI Number
- 3008840738
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Lot 26, Jalan 8, Bakar Arang Industrial Estate
- City
- Sungai Petani Kedah
- Country
- MY
Owner / Operator
- Firm Name
- HAMAGAWA INDUSTRIAL (M) SDN BHD
- Operator Number
- 10047158
- Address
- Lot 26, Jalan 8, Bakar Arang Industrial Estate
- City
- Sungai Petani
- State
- Kedah
- Postal Code
- 08000
- Country
- MY
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2014-07-08 |
Proprietary Names
Stem Impactor
Straight Broach Handle
Quick Connect Drill Shaft
Large Reamer Handle
Trial Liner, Neutral, 32mm Head, Size 52 54mm
Trial Liner, 10, 28mm Head, Size 52 54mm
Trial Liner, Neutral, 32mm Head, Size 48 50mm
Liner Impactor, 32mm
Quick Release Box Osteotome
Broach Handle power adapter
Tray, Tryon Acetabular System
Trial Femoral Head, 32mm, S
3.5 Hex Screw Driver Shaft
Trial Femoral Head, 36mm, L
Trial Femoral Head, 32mm, M
Trial Acetabular Cup, Size 48mm
Trial Liner, Neutral, 36mm Head, Size 52 54mm
Trial Liner, 10, 28mm Head, Size 48 50mm
Tryon 2 Tray
Kratos Trial Neck, Standard
Alignment Guide
Trial Liner, 10, 36mm Head, Size 56 58mm
Trial Liner, Neutral, 28mm Head, Size 44 46mm
Trial Femoral Head, 28mm, S
Trial Liner, 10, 28mm Head, Size 44 46mm
Straight Cup Inserter
Trial Femoral Head, 32mm, XL
Trial Acetabular Cup, Size 56mm
Trial Femoral Head, 36mm, S
Osteotomy Guide
Trial Liner, Neutral, 32mm Head, Size 60 68mm
Trial Femoral Head, 28mm, L
Trial Acetabular Cup, Size 60mm
Trial Liner, 10, 32mm Head, Size 52 54mm
Trial Femoral Head, 28mm, M
Quick Release Head Impactor
Trial Acetabular Cup, Size 64mm
Quick Release Stem Impactor
Trial Acetabular Cup, Size 46mm
Trial Acetabular Cup, Size 44mm
Trial Liner, 10, 36mm Head, Size 60 62mm
Trial Acetabular Cup, Size 58mm
Screw Driver Handle
Trial Femoral Head, 36mm, M
Calcar Reamer, Large
Trial Liner, Neutral, 36mm Head, Size 60 68mm
Drill Depth Gauge
Liner Impactor, 36mm
Trial Liner, 10, 32mm Head, Size 48 50mm
Trial Femoral Head, 32mm, L
Trial Acetabular Cup, Size 68mm
Tapered Pin Reamer
Trial Acetabular Cup, Size 50mm
Reamer Shaft
Stepped Entry Reamer
Trial Liner, Neutral, 32mm Head, Size 56 58mm
Trial Liner, 10, 32mm Head, Size 60 68mm
Trial Liner, 10, 36mm Head, Size 52 54mm
Trial Acetabular Cup, Size 52mm
Trial Liner, Neutral, 28mm Head, Size 52 54mm
Tray, Bonded Stem
Stem Positioner
Screw Inserter
Trial Liner, Neutral, 36mm Head, Size 56 58mm
IM Drill
Drill Guide
Liner Impactor, 28mm
Trial Acetabular Cup, Size 66mm
Kratos Trial Neck, H/O (Lateralized)
Trial Liner, Neutral, 28mm Head, Size 48 50mm
Trial Acetabular Cup, Size 62mm
Trial Acetabular Cup, Size 54mm
Trial Femoral Head, 36mm, XL
Trial Liner, 10, 32mm Head, Size 56 58mm
Dymaxeon Spine System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)