FDA Registration
Active
🇲🇾 Malaysia
Broach Handle, Left Double (10-95-3005)
Reg #: 3012217062
·
FEI: 3012217062
·
Expires 2025
Products
4
Proprietary Names
74
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- STRAITS ORTHOPAEDICS (MFG) SDN BHD
- Registration Number
- 3012217062
- FEI Number
- 3012217062
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No 2483 Tingkat Perusahaan 4A, Prai Free Industrial Zone
- City
- Perai Pulau Pinang
- Country
- MY
Regulatory Submissions
- 510(k) Number
- K161184
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 |
|---|---|---|---|---|---|
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2016-12-01 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2016-12-01 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2016-12-01 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2016-12-01 |
Proprietary Names
Broach Handle, Left Double (10-95-3005)
Offset Cup Impactor (10-95-2008)
Screw Hole Cover (10600001)
Straight Cup Impactor (10-95-2007)
Broach Handle, Straight (10-95-3003)
Broach Handle, Right Double (10-95-3006)
Apical Hole Cover (10600000)
FEMORAL RESECTION GUIDE LOCATING CAP (10-95-3000-3)
FEMORAL RESECTION GUIDE ASSEMBLY SLIDE CAP (10-95-3000-4)
FEMORAL RESECTION GUIDE ASSEMBLY LOCATOR DOWEL (10-95-3000-7)
FEMORAL RESECTION GUIDE ASSEMBLY (10-95-3000)
FEMORAL RESECTION GUIDE SLIDE (10-95-3000-2)
FEMORAL RESECTION GUIDE ASSEMBLY CAPTURE PIN (10-95-3000-5)
CALCAR PLANER, DIAMOND (10-95-3014)
HEAD IMPACTOR (10-95-3018)
FEMORAL RESECTION GUIDE ASSEMBLY BASE PLATE (10-95-3000-6)
FEMORAL RESECTION GUIDE LOCATING PIN (10-95-3000-1)
Neck Trial, Collared Stem, Lateral Size 0 (12-81-0100)
Neck Trial, Collared Stem, Lateral Size 5 (12-81-0105-01)
LATERALIZING REAMER (10-95-3010)
Neck Trial, Collared Stem, Standard Size 9 (12-81-0009-01)
Neck Trial, Collared Stem, Lateral Size 2 (12-81-0102-01)
Neck Trial, Collared Stem, Lateral Size 4 (12-81-0104-01)
CALCAR PLANER, DIAMOND, SLOTTED, MEDIUM (10-95-3081)
CANAL FINDER (10-95-3009)
Neck Trial, Collared Stem, Lateral Size 4 (12-81-0104)
CALCAR PLANER, WAGON WHEEL, LARGE (10-95-3052)
Neck Trial, Collared Stem, Standard Size 9 (12-81-0009)
CALCAR PLANER, TWIN BLADE, SMALL (10-95-3060)
Neck Trial, Collared Stem, Lateral Size 9 (12-81-0109)
Stem Inserter Offset (10-95-3022)
Neck Trial, Collared Stem, Lateral Size 11 (12-81-0111)
DIAMOND CALCAR PLANER, NON-SLOTTED, MD (10-95-3071)
Neck Trial, Collared Stem, Standard Size 0 (12-81-0000-01)
CALCAR PLANER, DIAMOND, SLOTTED, LARGE (10-95-3082)
Neck Trial, Collared Stem, Lateral Size 7 (12-81-0107-01)
Neck Trial, Collared Stem, Standard Size 11 (12-81-0011-01)
TROCAR TIP FEMORAL HEAD EXTRACTOR (10-95-3027)
DIAMOND CALCAR PLANER, NON-SLOTTED, LG (10-95-3072)
CALCAR PLANER, TWIN BLADE, LARGE (10-95-3062)
FEMORAL NECK RESECTION GUIDE (10-95-3000)
STRAIGHT STEM INSERTER (10-95-3017)
CALCAR PLANER, DIAMOND, SLOTTED, SMALL (10-95-3080)
Neck Trial, Collared Stem, Lateral Size 1 (12-81-0101-01)
Neck Trial, Collared Stem, Lateral Size 1 (12-81-0101)
Neck Trial, Collared Stem, Lateral Size 3 (12-81-0103-01)
Neck Trial, Collared Stem, Standard Size 10 (12-81-0010)
Neck Trial, Collared Stem, Lateral Size 10 (12-81-0110-01)
Neck Trial, Collared Stem, Lateral Size 7 (12-81-0107)
Neck Trial, Collared Stem, Lateral Size 12 (12-81-0112)
Neck Trial, Collared Stem, Lateral Size 12 (12-81-0112-01)
Neck Trial, Collared Stem, Standard Size 12 (12-81-0012-01)
Neck Trial, Collared Stem, Lateral Size 2 (12-81-0102)
Neck Trial, Collared Stem, Standard Size 7 (12-81-0007-01)
Neck Trial, Collared Stem, Standard Size 7 (12-81-0007)
CALCAR PLANER, WAGON WHEEL, SMALL (10-95-3050)
CALCAR PLANER, TWIN BLADE, MEDIUM (10-95-3061)
CALCAR PLANER, WAGON WHEEL, MEDIUM (10-95-3051)
Neck Trial, Collared Stem, Standard Size 0 (12-81-0000)
Neck Trial, Collared Stem, Standard Size 11 (12-81-0011)
Neck Trial, Collared Stem, Lateral Size 6 (12-81-0106-01)
Neck Trial, Collared Stem, Lateral Size 10 (12-81-0110)
DIAMOND CALCAR PLANER, NON-SLOTTED, SM (10-95-3070)
Neck Trial, Collared Stem, Standard Size 8 (12-81-0008)
Neck Trial, Collared Stem, Lateral Size 8 (12-81-0108)
Neck Trial, Collared Stem, Standard Size 10 (12-81-0010-01)
Neck Trial, Collared Stem, Standard Size 8 (12-81-0008-01)
Neck Trial, Collared Stem, Lateral Size 0 (12-81-0100-01)
Neck Trial, Collared Stem, Lateral Size 9 (12-81-0109-01)
Neck Trial, Collared Stem, Standard Size 12 (12-81-0012)
Neck Trial, Collared Stem, Lateral Size 5 (12-81-0105)
Neck Trial, Collared Stem, Lateral Size 6 (12-81-0106)
Neck Trial, Collared Stem, Lateral Size 8 (12-81-0108-01)
Neck Trial, Collared Stem, Lateral Size 3 (12-81-0103)
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)