FDA Registration
Active
🇲🇾 Malaysia
Ortho Solutions Sdn Bhd
Reg #: 3012755988
·
FEI: 3012755988
·
Expires 2026
Products
29
Proprietary Names
5
Establishment Types
1
Classifications
29
Registration Details
- Registration Name
- Ortho Solutions Sdn Bhd
- Registration Number
- 3012755988
- FEI Number
- 3012755988
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2821, Tingkat Perusahaan 5A, Prai Industrial Estate
- City
- Prai, Penang Pulau Pinang
- Country
- MY
Owner / Operator
- Firm Name
- Ortho Solutions Sdn Bhd
- Operator Number
- 10079077
- Address
- 89 South Commerce Way, Suite 990
- City
- Bethlehem
- State
- PA
- Postal Code
- 18017
- Country
- US
- Correspondent
- Lisa Boyle
US Agent
- Business Name
- Exalta-PNG
- Contact Name
- Tania Shammo
- Address
- 10325 58th Pl
- City
- Kenosha
- State
- WI
- ZIP
- 53144
- Country
- US
- [email protected]
- Phone
- 262 2886450
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2020-11-17 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2024-03-05 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2024-03-05 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2020-12-22 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2020-11-17 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2020-11-17 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2020-11-19 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2020-11-19 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2026-01-07 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2024-03-22 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2023-05-02 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2020-11-18 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2024-11-11 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2023-12-21 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2024-03-22 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2023-06-07 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2024-10-09 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2023-06-07 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2023-06-07 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2023-06-07 |
| Screwdriver, Surgical | LRZ | Class 1 | General, Plastic Surgery | No | 2023-05-02 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2020-11-17 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 2020-12-22 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2024-03-05 |
| Template | HWT | Class 1 | Orthopedic | No | 2020-11-17 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2020-12-22 |
| Instrument, Surgical, Non-Powered | HAO | Class 1 | Neurology | No | 2024-03-05 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2020-11-17 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2020-11-19 |
Proprietary Names
Guide, Surgical, Instrument
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
FORCEPS
Paragon 28 External Ring Fixation System
ROD, FIXATION, INYRAMEDULLARY AND ACCESSORIES
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)