Catalog Number

-

Brand Name

ICON

Version/Model Number

68-7000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 11, 2014

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

K111448

Product Code

NKB

Product Code Name

Orthosis, spinal pedicle fixation, for degenerative disc disease

Public Device Record Key

79cf7a9f-0893-4067-94dd-8b99e3126869

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2014

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-