FDA Registration
Active
🇮🇳 India
Threaded Knob
Reg #: 3016443334
·
FEI: 3016443334
·
Expires 2025
Products
4
Proprietary Names
16
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
- Registration Number
- 3016443334
- FEI Number
- 3016443334
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- SURVEY NO-1540, BESIDE TORRENT PHARMA,, AHMEDABD-MEHSANA HIGHWAY, VILLAGE-RAJPUR
- City
- KADI Gujarat
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K222516
Owner / Operator
- Firm Name
- SOLCO BIOMEDICAL CO
- Operator Number
- 10077960
- Address
- 5 & 6, 3rd Floor, B. Jadav Chambers,, Ashram Road
- City
- AHMEDABAD
- State
- Gujarat
- Postal Code
- 380009
- Country
- IN
US Agent
- Business Name
- Carrasco
- Contact Name
- Mateo Carrasco
- Address
- 1815 Barker drive
- City
- Winter Park
- State
- FL
- ZIP
- 32789
- Country
- US
- [email protected]
- Phone
- 407 2849480
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2023-09-08 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2023-09-08 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2023-09-08 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2023-09-08 |
Proprietary Names
Threaded Knob
Retention Sleeve
Pusher Bar Shaft
Modular Tulip Inseter quick connect carrier
Tightener Sleeve
Cannulated Screw Inserter Shaft
Reduction Pusher - Bar End
Extended Tab Pusher - Bar End
ARMS WELDMENT, ROD ARM
Set Screw Inserter
Outer Sleeve
Low Top Pusher - Bar End
Set Screw Tightener
Tower
Bone Screw Inserter Driver, Cannulated
ARMS WELDMENT, PUSH ARM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)