Catalog Number

PNNS5040N

Brand Name

CarboClear X Pedicle Screw System

Version/Model Number

Pedicle Screw - Non Cannulated

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K210716,K210716

Product Code

NKB

Product Code Name

Thoracolumbosacral Pedicle Screw System

Public Device Record Key

074ab3af-54d7-4763-8ce6-f6711756b6d3

Public Version Date

July 06, 2021

Public Version Number

1

DI Record Publish Date

June 28, 2021

Package DI Number

17290110209824

Quantity per Package

2

Contains DI Package

07290110209827

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-