Catalog Number

CS02-0101

Brand Name

Paeon Posterior Cervical Fixation System

Version/Model Number

CS02-0101

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HXB

Product Code Name

Probe

Public Device Record Key

cd12923c-f7dd-4ae5-addc-8361fad47f02

Public Version Date

May 11, 2022

Public Version Number

1

DI Record Publish Date

May 03, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-