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
Phone
407 2849480

Products

Device Name Product Code
Appliance, Fixation, Spinal Intervertebral Body KWQ
Appliance, Fixation, Spinal Interlaminal KWP
Thoracolumbosacral Pedicle Screw System NKB

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)