Catalog Number

PNNSC8595FN

Brand Name

CarboClear X Pedicle Screw System

Version/Model Number

Pedicle Screw - Fenestrated

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

K190526,K210716,K190526,K210716

Product Code

NKB

Product Code Name

Thoracolumbosacral Pedicle Screw System

Public Device Record Key

d7d74f18-83b3-405c-abce-f0cdc5183c00

Public Version Date

January 24, 2022

Public Version Number

1

DI Record Publish Date

January 16, 2022

Package DI Number

17290117350444

Quantity per Package

2

Contains DI Package

07290117350447

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-