4CIS VERTU SPINE SYSTEM - Mono-axial Reduction Cannulated Pedicle Screw, Ø - SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED

Duns Number:868354728

Device Description: Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 40 mm LengthThe Spinal Fixation S Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, 40 mm LengthThe Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, nuts, transverse (cross) link and associated instruments. Rigid fixation is provided by pedicle screws inserted into the vertebral body through pedicle of the lumbar spine via posterior approach. This system will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion through open surgery. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the mature patient. The implant components are supplied non-sterile single use and are fabricated from titanium alloy (Ti-6A1-4V ELI) conforms to ASTM F136. Also, Specialized instruments are available for the application and removal of the Spinal Fixation System

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More Product Details

Catalog Number

2808-7540

Brand Name

4CIS VERTU SPINE SYSTEM

Version/Model Number

AISP-2808-7540

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K202498

Product Code Details

Product Code

NKB

Product Code Name

Thoracolumbosacral Pedicle Screw System

Device Record Status

Public Device Record Key

5f91ca4e-3c0a-46f7-ade1-0e47cc22e330

Public Version Date

April 05, 2021

Public Version Number

1

DI Record Publish Date

March 27, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 674