FDA Registration
Active
🇮🇳 India
Modular Screw Body, T25, D4.5xL30mm
Reg #: 3016443334
·
FEI: 3016443334
·
Expires 2025
Products
3
Proprietary Names
23
Establishment Types
1
Classifications
3
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
- K173185
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 |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2022-02-04 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2022-02-04 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2022-02-04 |
Proprietary Names
Modular Screw Body, T25, D4.5xL30mm
Zero Step Screw Body, D5.5XL45-55 mm
Modular Screw Body, T25, D4.5xL40mm
Modular Screw Body, T25, D4.5xL25mm
Tap, Cortical, 4.5mm
DEROTATOR
Adaptor SQ 15 to 1/4" QC
MIS Access Tower, Segmented, Flexible
Rod Reduction Housing
Tap, Cortical, Cannulated, 4.5mm
Modular Screw Body, T25, D4.5xL35mm
MIS Access Tube, Continuous, Flexible
Adaptor QC, 1/4" SQ Female
Zero Step Screw Body, D4.5XL30mm
T-handle, SQ 15
Zero Step Screw Body, D6.5XL45-55 mm
Rod to Rod Connector, 30, LARGE
Rod to Rod Connector, 30, SMALL
K-wire Stylet, 65mm
Rod to Rod Connector, 0, LARGE
K-wire Stylet, 45mm
Rod to Rod Connector, 0, SMALL
K-wire Stylet, 55mm
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)