Catalog Number

-

Brand Name

Neuro & Craniofacial Fixation System

Version/Model Number

CR102ST

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K091679

Product Code

JEY

Product Code Name

Plate, Bone

Public Device Record Key

f9c7721f-1369-4383-a553-3871d0ebd05e

Public Version Date

February 05, 2021

Public Version Number

4

DI Record Publish Date

July 31, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-