4CIS® Chiron Spinal Fixation System - 4CIS® Chiron Poly Axial Cannulated Screw Ø4.5 X - SOLCO BIOMEDICAL CO.,LTD.

Duns Number:687844241

Device Description: 4CIS® Chiron Poly Axial Cannulated Screw Ø4.5 X 30mm (Rod Ø5.5)

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More Product Details

Catalog Number

4146-4530

Brand Name

4CIS® Chiron Spinal Fixation System

Version/Model Number

4146-4530

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

K190471

Product Code Details

Product Code

NKB

Product Code Name

Thoracolumbosacral Pedicle Screw System

Device Record Status

Public Device Record Key

18a40bad-d401-4a85-bf6b-babef0a3b19e

Public Version Date

November 19, 2019

Public Version Number

1

DI Record Publish Date

November 11, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SOLCO BIOMEDICAL CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 969
2 A medical device with a moderate to high risk that requires special controls. 6429