4CIS® Chiron Spinal Fixation System - Spinal Rigid Rod Ø6.0X130mm - SOLCO BIOMEDICAL CO.,LTD.

Duns Number:687844241

Device Description: Spinal Rigid Rod Ø6.0X130mm

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More Product Details

Catalog Number

4338-6130

Brand Name

4CIS® Chiron Spinal Fixation System

Version/Model Number

4338-6130

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

e7276a65-85f1-4069-82e2-0df2a2c14d62

Public Version Date

June 01, 2020

Public Version Number

1

DI Record Publish Date

May 22, 2020

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